http://www.devicespace.com/DeviceSpace RSS Generatorhttp://rss.biospace.com/images/deviceSpaceLogo.gifhttp://www.BioSpace.com/news.aspx?SectionId=2Copyright (C) 2007http://www.devicespace.com/news_story.aspx?StoryID=95922&full=1PA -- Some 135 jobs are to be created in the Donegal Gaeltacht, the first major employment boost for the area since local TD Mary Coughlan was appointed Tanaiste and Minister for Enterprise. International medical diagnostics firm Randox Laboratories is to invest 7.5 million euro at a manufacturing and research and development plant in Dungloe. A range of products will be made at the site including...Mon, 12 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95880&full=1HUDSON, N.H., May 12 /PRNewswire/ -- Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE(TM) Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS)...Mon, 12 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95899&full=1<p> TEL AVIV, Israel, May 12 /PRNewswire/ -- Medinol is proud to announce that it has received CE Mark for its Presillion(TM) CoCr Coronary Stent, enabling physicians to treat coronary artery lesions with a technologically innovative flexible closed cell design stent.</p><p> Presillion(TM) preserves the superb scaffolding the unprecedented balance of flexibility and conformability identified...Mon, 12 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95914&full=1<p> SAN CLEMENTE, Calif., May 12 /PRNewswire/ -- USGI Medical, Inc. (USGI), the leader in incisionless surgery, announced today that the company has licensed its incisionless surgery technology to Intuitive Surgical for use in medical robotics applications. Financial terms of the deal were not disclosed.</p><p> "We've been impressed by USGI's technical and clinical development including their...Mon, 12 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95933&full=1SAN ANTONIO--(BUSINESS WIRE)--One of the Southwest Foundation for Biomedical Researchs longest running departments is being spun off as a private, for-profit business enterprise based on the massive body of work the department has accumulated in female reproductive and related health issues.</p><p>SFBR President John Kerr, who first envisioned the concept, said the new company, Evestra Inc., is...Mon, 12 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95931&full=1<p> ST. LOUIS, May 12 /PRNewswire/ -- Veran Medical Technologies, a medical device start-up company, has secured $4.75M in venture capital and private financing to drive adoption of its IG4 delivery system for minimally invasive biopsy and ablation of cancer. St. Louis-based Prolog Ventures led the round and was joined by Advantage Capital Partners and existing private investors. Veran also relocated...Mon, 12 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95923&full=1BETHLEHEM, Pa.--(BUSINESS WIRE)--Neuromonics Inc. today announced that Richard Giancola has joined the company as chief executive officer and member of its board of directors. Giancola, who was most recently vice president and general manager, Latin America, for Cochlear Americas, brings more than 25 years of experience driving multi-million dollar sales growth for global medical device companies...Mon, 12 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95875&full=1SUNNYVALE, Calif., May 12 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD - News) today announced it has signed a group purchasing contract with Premier, Inc., one of the largest U.S. Group Purchasing Organizations (GPOs) with more than 1,500 participating hospitals and 42,000 other healthcare sites. In conjunction with this agreement, Cepheid has also signed a preferred vendor agreement with the Western...Mon, 12 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95882&full=1BOULDER, Colo., May 9 /PRNewswire/ -- SomaLogic, Inc. announced today that SomaLogic and Otsuka Pharmaceutical Co., Ltd. entered into a collaboration agreement to use SomaLogic's proprietary aptamer technology to discover and develop novel diagnostic products and to design research tools that will enhance Otsuka's pharmaceutical discovery and development efforts. Under the terms of the agreement, SomaLogic...Mon, 12 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95723&full=1<p> WALTHAM, Mass., May 9 /PRNewswire-FirstCall/ -- Inverness Medical Innovations today announced that its previously announced acquisition of Matria Healthcare, Inc. was successfully completed and effective prior to the opening of business today, May 9, 2008. Matria, headquartered in Marietta, Georgia, provides comprehensive, integrated health management services particularly in the areas of...Fri, 09 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95725&full=1<p> SAN JOSE, Calif., May 9 /PRNewswire-FirstCall/ -- VNUS(R) Medical Technologies, Inc. today announced that the U.S. Patent & Trademark Office has decided to allow a second continuation patent application related to the patents in the VNUS patent infringement lawsuit against suppliers of endovenous laser products. This comes on the heels of the Patent Office's decision last month to allow VNUS...Fri, 09 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95743&full=1<p> NEW YORK, May 9 /PRNewswire-FirstCall/ -- Pulmo BioTech Inc. announced today that it has increased its stake in PulmoScience Inc. by 10%, taking its total holdings to 61% in this Company which owns a unique Molecular Imaging Diagnostic Technique for pulmonary related medical conditions.</p><p> Pulmo BioTech CEO Garry McCann said, "We are confident the Molecular Imaging technology, developed...Fri, 09 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95787&full=1GAINESVILLE, Fla.--(BUSINESS WIRE)--Exactech Inc. (Nasdaq:EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today that it has entered into definitive agreements with certain institutional investors to sell 877,391 shares of its common stock at a price of $23.00 per share, resulting in gross proceeds of approximately...Fri, 09 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95790&full=1ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE: STJ) today announced it will unveil its new corporate identity to physician customers at the 88th Annual Meeting of the American Association of Thoracic Surgery (AATS) on May 10, at EuroPCR on May 13 and at the Heart Rhythm Societys (HRS) Annual Scientific Sessions on May 14. The new brand identity is designed to communicate the company...Fri, 09 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95727&full=1<p> ORLANDO, Fla., May 9 /PRNewswire-FirstCall/ -- PainCare Holdings, Inc. , a provider of pain-focused medical and surgical solutions and services, today announced that it will voluntarily withdraw its common stock from listing on the American Stock Exchange ("AMEX"). PainCare's Board of Directors considered several factors that include the following:</p><p></p><p> For a recap of the previously...Fri, 09 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95717&full=1<p> MIAMI, May 8 /PRNewswire/ -- Globus Medical, Inc., the largest privately held spinal implant manufacturer in the world and a recognized leader in motion preservation technology, today announced the completion of enrollment in its SECURE(R)-C Cervical Artificial Disc IDE study. The SECURE(R)-C device is designed to mimic the normal motion of the spine in order to alleviate pain and restore function...Fri, 09 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95509&full=1MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT - News) today announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs...Thu, 08 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95505&full=1HUDSON, N.H., May 8 /PRNewswire/ -- Atrium Medical Corporation is pleased to announce it has obtained US FDA 510(K) approval for two new Omega 3 surgical mesh products; C-QUR Edge(TM) V-Patch and C-QUR Lite(TM) V-Patch.</p><p>These new products are indicated for use in the surgical repair and reinforcement of soft tissue, including hernia repair -- a common procedure performed more than 700,0...Thu, 08 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95512&full=1NATICK, Mass., May 8 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX - News) today announced U.S. Food and Drug Administration (FDA) approval of its ALTRUA(TM) family of pacemakers. ALTRUA is Boston Scientific's most advanced pacemaker and delivers enhanced therapies while maintaining its small size and battery longevity. It is the first Boston Scientific-branded pacemaker to treat...Thu, 08 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95466&full=1ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark approval of the Strada Carotid Guiding Sheath, a flexible tube through which physicians can deliver balloon catheters, stents and other tools to open blockages in the carotid arteries. The Strada Carotid Guiding Sheath is designed specifically to...Thu, 08 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95511&full=1ST. LOUIS--(BUSINESS WIRE)--Covidien (NYSE: COV, BSX: COV) today announced that the U.S. Food and Drug Administration (FDA) has approved Covidien Imaging Solutions contrast delivery system with radio-frequency identification (RFID) technology. The components integrate novel RFID technology to create a system that is designed to enhance patient safety by reducing the risk of medical errors in radiology...Thu, 08 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95303&full=1CHICAGO (Reuters) - Medtronic Inc on Tuesday said it would eliminate about 1,100 jobs this year, or almost 3 percent of its work force, in businesses whose growth has slowed, including its flagship heart rhythm device unit.Wed, 07 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95304&full=1MADISON, Conn., May 6 /PRNewswire/ -- Vascular Insights LLC announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ClariVein(TM) infusion catheter for infusion of physician-specified agents in the peripheral vasculature.</p><p>ClariVein(TM) is a percutaneous, 2 2/3 Fr (0.035") catheter, containing a rotating wire driven by a motor, that...Wed, 07 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95285&full=1NATICK, Mass., May 7 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX - News) today announced CE Mark approval and market launch of its ALTRUA(TM) family of pacemakers. ALTRUA is Boston Scientific's most advanced pacemaker and delivers enhanced therapies while maintaining its small size and battery longevity. It is the first Boston Scientific-branded pacemaker to treat bradycardia...Wed, 07 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95292&full=1MIAMI, May 7 /PRNewswire-FirstCall/ -- OPKO Health, Inc. (Amex: OPK - News) today announced that it has acquired Vidus Ocular, Inc., a privately held company that is developing Aquashunt(TM), an innovative shunt to treat glaucoma, the second leading cause of blindness in the U.S., in an all-stock transaction. Aquashunt is an implantable physiologic device that is designed to address the shortcomings...Wed, 07 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95283&full=1Indy Star -- DCL Medical Laboratories, a full-service medical testing laboratory focusing on women's health, today is expected to announce a major expansion at its Northwestside headquarters. Gov. Mitch Daniels is scheduled to make an economic development announcement at 10 a.m. today at DCL headquarters, 9550 Zionsville Road. The site is a former Dow AgroSciences building leased from Holladay Properties...Wed, 07 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95146&full=1<p> NEWPORT NEWS, Va., May 6 /PRNewswire/ -- Dilon Technologies announced today that it has received CE Mark (Conformite Europeenne) approval for the commercial sale of the Dilon 6800 Gamma Camera in European Union member countries. The Dilon system is a high-resolution gamma camera that enables molecular imaging of the breast and other small organs for early cancer detection.</p><p> "I am delighted...Wed, 07 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95323&full=1<p> PITTSBURGH, May 7 /PRNewswire/ -- Cohera Medical, Inc., a rapidly growing medical device company developing a suite of wound management systems and surgical adhesives, announced today that it has closed an insider round of financing for over $7.6 Million. The proceeds of this transaction will support the growth of the company through pilot clinical trials for its lead product, TissuGlu(R), a...Wed, 07 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95210&full=1<p> TORONTO, May 6 /PRNewswire/ - Dalton Pharma Services, a privately owned Canadian pharmaceutical services provider, and Thermo Fisher Scientific have entered into an agreement under which Dalton will use a proprietary Thermo Fisher manufacturing process to produce nucleic-acid biopolymers for pharmaceutical use.</p><p> Utilizing enzyme-based technology developed at Thermo Fisher Scientific...Wed, 07 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95093&full=1<p> ISSAQUAH, Wash., May 5 /PRNewswire/ -- Applied Precision(R) LLC, a leading provider of imaging, measurement and analysis systems for the life sciences Industries, today announced the sale of its Life Sciences business unit to a group led by Senior Management and Telegraph Hill Partners of San Francisco. The resulting company, Applied Precision, Inc., will be headquartered in its current Seattle...Tue, 06 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95119&full=1eiNav/Artemis Helps Pinpoint Prostate Cancer, Provides a Map for Follow-up Care</p><p>GRASS VALLEY, Calif.--(BUSINESS WIRE)--A new imaging device, eiNav/Artemis, now officially cleared by the U.S. Food and Drug Administration (FDA), offers urologists breakthrough technology that will significantly help in the fight against prostate cancer. Artemis, designed by Eigen, a Northern California...Tue, 06 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95099&full=1<p> MAITLAND, Fla., May 6 /PRNewswire/ -- Scient'x, a privately held manufacturer of innovative spinal implant technologies, announced today that they have received FDA 510(k) clearance to market their new Isobar DUO(TM) Dynamic Stabilization System. This system is an extension of the original Isobar Dynamic TTL-Rod(R) which received FDA 510(k) clearance in 1998. The Isobar Duo(TM) has been cleared...Tue, 06 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95084&full=1FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates (Gore) announced today it received approval to apply the CE Mark for the commercial sale of GORE PRECLUDE Vessel Guard, the first non-biological membrane indicated as a cover for vessels following anterior vertebral surgery. This advanced biomaterial reduces the risk of potential vascular injury by providing a permanent and visible plane of...Tue, 06 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95105&full=1An early-stage study examining use of a St. Jude Medical Inc. (STJ) brain- stimulation device in severely depressed patients showed it had a positive effect in most cases, the company said.Tue, 06 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95082&full=1PALO ALTO, Calif., May 6 /PRNewswire/ -- PEAK Surgical, Inc., a medical device company that is developing new tissue dissection systems based on a proprietary technology, released results from a preclinical study demonstrating that its PEAK PlasmaBlade(TM) cut freshly excised human abdominal tissue with little thermal tissue injury compared with traditional electrosurgery. The PEAK PlasmaBlade is a...Tue, 06 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95092&full=1<p> DRIEBERGEN, Netherlands, May 5 /PRNewswire/ -- Pioneer Surgical Technology's European subsidiary will present the latest clinical results of its NuBac Disc Arthroplasty System at the Spine Arthroplasty Society (SAS) meeting in Miami (Florida, US). The presence of Pioneer at SAS includes the introduction of its signature P3 (Pioneer Peek-on-Peek) Technology. The NuBac is the flagship of this...Tue, 06 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94925&full=1NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today it has signed a definitive agreement to sell its ConvaTec business unit to Nordic Capital Fund VII (Nordic Capital) and Avista Capital Partners (Avista) for $4.1 billion subject to adjustments based on ConvaTecs audited 2007 financial statements and closing working capital. ConvaTec is a world leader in the development...Mon, 05 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94931&full=1SOLANA BEACH, Calif.--(BUSINESS WIRE)--The U.S. Food and Drug Administration has cleared for marketing a new safety engineered short-term peripheral Intra-Venous (IV) Catheter. The product, VantageCath, is designed to significantly reduce exposure to bloodborne pathogens during the placement of the catheter and also provide the clinician with desirable feature sets.</p><p>Existing safety engineered...Mon, 05 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94933&full=1MELVILLE, N.Y.--(BUSINESS WIRE)--Bovie Medical Corporation (the Company) (Amex: BVX - News), a manufacturer and marketer of electrosurgical products, today announced a CE Mark for its Modular Ergonomic Instruments (MEG laparoscopic line), allowing the MEG Laparoscopic line to be marketed throughout the European Union.</p><p>The patent-pending modular forceps and accessories are designed to provide...Mon, 05 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94935&full=1YOKNEAM, Israel, May 5 /PRNewswire/ -- Lumenis Ltd. announced plans to align their Ophthalmic Strategic Business Unit (Lumenis Vision) for aggressive growth while at the same time ensuring the highest standards of quality and reliability.</p><p>Lumenis' Ophthalmic Unit has been streamlined to report to Mr. Gideon Sturlesi, who will lead the unit for the present time in addition to his role as Lumenis...Mon, 05 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94977&full=1CHALFONT ST GILES, England--(BUSINESS WIRE)--GE Healthcare, a subsidiary of the General Electric Company (NYSE:GE - News) announced today that it has signed a non-exclusive agreement with Merck & Co., Inc. to share technology on imaging of the lungs that may help to advance respiratory treatment development. Under terms of the agreement, Merck will be granted access to Spin Signal TechnologyTM (SST...Mon, 05 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94920&full=1<p> KALAMAZOO, Mich., May 2 /PRNewswire-FirstCall/ -- Stryker Corporation announced today that its Biotech division has received a warning letter from the U. S. Food and Drug Administration (FDA) related to quality systems and compliance issues at its Hopkinton, Massachusetts location.</p><p> The warning letter concerns observations made during an inspection that was initiated in September ...Mon, 05 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94936&full=1TEL AVIV, Israel--(BUSINESS WIRE)--InspireMD announced today continued positive results from the MGuard Coronary Stent First-in-Man, multi-center ongoing trial in Germany. This study aims at establishing the safety and efficacy of MGuard Coronary Stent in high risk patients with complex lesions. The study primary end point demonstrated 0% major adverse cardiac events (MACE) after 30 days in 60 patients...Mon, 05 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95050&full=1<p> FRAMINGHAM, Mass. and SYDNEY, Australia, May 5 /PRNewswire/ -- HeartWare Limited today announced that it had received conditional approval from the United States Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) for its lead product, the HeartWare(R) Left Ventricular Assist System (LVAS).</p><p> The granting of conditional IDE approval by the FDA enables the...Mon, 05 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94975&full=1MOUNTAIN VIEW, Calif., May 5 /PRNewswire/ -- Cardiva Medical, Inc., a privately held medical device company, announced today it has closed a $15.5 million private equity financing lead by PTV Sciences. Also investing in this financing were existing investors Galen Partners, Sycamore Ventures, Amkey Ventures, Lexli Investment, and Eminent Venture Capital. Cardiva intends to use the proceeds of the financing...Mon, 05 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=95041&full=1ALISO VIEJO, Calif., May 5, 2008 (PRIME NEWSWIRE) -- SenoRx, Inc. (Nasdaq:SENO) today announced that it has received clearance to modify a warning on its Contura(tm) Multi-Lumen Radiation Balloon (MLB) Catheter product label from the U.S. Food and Drug Administration. The revised warning clarifies the use of the Contura MLB in cases in which there is less than 5 millimeters of skin spacing.Mon, 05 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94938&full=1BOSTON, May 2 (Reuters) - General Electric Co has resumed production of X-ray machines at a Salt Lake City, Utah, facility shut since late 2006 because of quality-control issues raised by U.S. regulators.Mon, 05 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94946&full=1<p> SAN DIEGO, May 5 /PRNewswire-FirstCall/ -- Volcano Corporation , a leading manufacturer and developer of intravascular ultrasound (IVUS), functional measurement (FM) and Optical Coherence Tomography (OCT) products designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, announced today participation in SATURN (Study of Coronary Atheroma by InTravascular Ultrasound...Mon, 05 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94929&full=1FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates (Gore) today announced that it has received approval from the US Food & Drug Administration (FDA) to proceed with the Gore REDUCE* Clinical Study. The Gore REDUCE Clinical Study is a prospective, randomized, multi-center, multinational trial designed to demonstrate safety and effectiveness of the GORE HELEX Septal Occluder for Patent Foramen...Mon, 05 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94818&full=1VANCOUVER, May 1 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin marketing sizes 3-0 and 4-0 of its Quill Self-Retaining System (SRS) Polydioxanone (PDO) product line. The Quill SRS PDO is a longer...Fri, 02 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94909&full=1AUSTIN, Texas--(BUSINESS WIRE)--ArthroCare Corp. (Nasdaq: ARTC), a leader in developing state-of-the-art, minimally invasive surgical products, announced today that it has acquired OrtoConcept Scandinavia, a medical device distributor based in Aarhus, Denmark, and specializing in the distribution of sports medicine and spine devices to surgeons throughout Denmark, Norway and Sweden.</p><p>"The...Fri, 02 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94840&full=1- Company Raises Equity and Strengthens Board of Directors -</p><p>GLASGOW, Scotland--(BUSINESS WIRE)--Mpathy Medical, a rapidly growing medical device company which has developed and brought to market a range of surgical solutions used to restore pelvic health to women, announced today that it has raised new equity finance from Archangel Informal Investment and Scottish Enterprises co-investment...Fri, 02 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94811&full=1MONTREAL, QUEBEC--(MARKET WIRE)--May 2, 2008 -- During a conference call held yesterday, Sonomax Hearing Healthcare Inc. (CDNX:SHH.V - News) announced that Mr. Dan Casey would become the Chief Executive Officer of the company effective immediately, replacing Mr. Barry Schwartz. Mr. Schwartz will remain the non-executive Chairman of the Board of the corporation. Mr. Casey worked at Future Electronics...Fri, 02 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94802&full=1BOSTON, April 28 /PRNewswire-USNewswire/ -- Following an investigation by the U.S. Department of Labor, New Jersey-based Quest Diagnostics Inc. has agreed to pay 238 employees across the country a total of $688,772 in overtime back wages due under the federal Fair Labor Standards Act (FLSA).</p><p>The investigation by the departments Wage and Hour Division, involving the companys Cambridge, Mass...Fri, 02 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94634&full=1MELVILLE, N.Y.--(BUSINESS WIRE)--Bovie Medical Corporation (the Company) (Amex: BVX - News), a manufacturer and marketer of electrosurgical products, today announced it has signed an agreement with Boston Scientific Corporation (NYSE: BSX - News) to acquire technology, patents, and assets related to the use of conductive sintered steel as an electrode for radio frequency (RF) cutting and coagulation...Thu, 01 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94581&full=1FREMONT, Calif.--(BUSINESS WIRE)--AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced today that its AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the device for balloon dilatation of lesions in the iliac, femoral...Thu, 01 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94590&full=1VANCOUVER, BRITISH COLUMBIA--(MARKET WIRE)--May 1, 2008 -- Pyng Medical Corp. (CDNX:PYT.V - News) today announced it has received regulatory clearance from both the US Food and Drug Administration (FDA) and Health Canada to market its FAST1(TM) Intraosseous (IO) Infusion System for use in adolescent populations, in addition to adults throughout the US and Canada, effective immediately. FAST1(TM) also...Thu, 01 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94638&full=1Bizjournal -- PhotoMedex Inc. said Thursday that the NASDAQ stock market has warned that it could be delisted because its stock is below the $1 minimum bid price requirement. The Montgomeryville, Pa.-based medical device company's stock price, which closed Wednesday at 94 cents, has been below $1 since March 14. Thu, 01 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94644&full=1HUNTERSVILLE, N.C. (AP) -- Orthopedic product maker Orthofix International raised its full-year profit guidance Thursday on expected cost reductions. The company said it now expects 2008 profit between $1.65 and $1.80 per share, a 20 cents per share boost to its prior guidance range. Analysts polled by Thomson Financial currently predict profit of $1.46 per share. Orthofix said it expects to record...Thu, 01 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94704&full=1ONTARIO, Calif.--(BUSINESS WIRE)--DPS Instruments, Inc., manufacturer of the worlds only modular gas chromatograph systems, announced that it has formed a new company to better serve the European community called DPS Instruments Europe GmbH.</p><p>David Pierce, President of DPS Instruments, said, The new company, strategically located near Bonn Germany, has been formed as the central sales and...Thu, 01 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94592&full=1SAN DIEGO, May 1 /PRNewswire/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today the CE marking of the BD GeneOhm(TM) VanR assay for the rapid detection of vanA and vanB genes, which are associated with vancomycin-resistant Enterococci (VRE). BD will immediately begin commercializing this important new assay throughout Europe.</p><p>The BD GeneOhm VanR assay is...Thu, 01 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94584&full=1SAN DIEGO, May 1 /PRNewswire/ -- Astute Medical, Inc. today announced it has raised $6.25 million in an initial financing round led by De Novo Ventures. The proceeds will primarily be used to fund research and development aimed at the identification and validation of protein biomarkers with the goal of finding high potential diagnostic candidates.</p><p>"This investment is an exciting event that...Thu, 01 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94683&full=1BILLERICA, Mass.--(BUSINESS WIRE)--Advanced Supercon, Inc. (ASCI) in Billerica, Massachusetts, a new subsidiary of Bruker Corporation (NASDAQ: BRKR), announced today that it has hired Thomas M. Rosa as Chief Financial Officer and Senior Vice President, and that it is establishing business development and customer support operations in the U.S. under Mr. Rosas leadership. The manufacturing operations...Thu, 01 May 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94375&full=1ORANGE COUNTY, Calif., April 30 /PRNewswire-FirstCall/ -. Beckman Coulter, Inc. (NYSE: BEC - News) announced today that it has licensed certain rights to testing for the hepatitis C virus (HCV) from Siemens Healthcare Diagnostics. Under the agreement, Beckman Coulter can develop, manufacture and sell a quantitative viral load HCV blood test for use on the company's molecular diagnostic instrument...Wed, 30 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94373&full=1SAN MATEO, Calif., April 30 /PRNewswire-FirstCall/ -- BioForm Medical, Inc. (Nasdaq: BFRM - News) announced that it has acquired substantially all of the assets of privately-held, Denver, CO based, Advanced Cosmetic Intervention, Inc. (ACI) and associated technology rights for $12 million cash, plus future royalties and a potential sales-related milestone. This acquisition provides BioForm Medical...Wed, 30 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94424&full=1ExploraMed NC4: The stealthy Mountain View company has raised $18.5 million of an expected $20 million first funding round, we're told. The medical-device start-up doesn't have a Web site, and doesn't even seem to have its own address yet. Instead, ExploraMed NC4 - the name is a placeholder intended to obscure the start-up's strategy - is still housed at ExploraMed, a medical-device incubator backed...Wed, 30 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94428&full=1IRVINE, Calif.--(BUSINESS WIRE)--CoreValve (www.corevalve.com) announced today that it has appointed Daniel T. Lemaitre as Chief Executive Officer, effective immediately. He succeeds Jacques Sguin, M.D., Ph.D., co-founder of CoreValve, who will remain as Chairman of the Board.</p><p>Mr. Lemaitre has led Medtronics corporate strategic planning and corporate development functions since 2006 and...Wed, 30 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94387&full=1MINNEAPOLIS--(BUSINESS WIRE)--American Medical Systems Holdings, Inc. (NASDAQ: AMMD - News), today announced that the Companys Board of Directors has named Anthony P. Bihl, III, as Chief Executive Officer and President effective April 30, 2008. Mr. Bihl, who also joins the Board of Directors, brings more than twenty-five years of leadership experience in the medical equipment and diagnostics industries...Wed, 30 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94376&full=1MERRIMACK, New Hampshire, April 30 /PRNewswire/ -- DxTech LLC ("DxTech"), an innovation company focused on putting high-quality diagnostic information in the hands of physicians in real time, has entered into a long-term strategic alliance with Nicholas Piramal India Limited ("NPIL"), one of the largest pharmaceutical and healthcare companies in India. The alliance includes a License and Development...Wed, 30 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94379&full=1VENLO, The Netherlands and BEVERLY, Mass., April 30, 2008 (PRIME NEWSWIRE) -- QIAGEN (NasdaqGS:QGEN - News) (Frankfurt:QIA.F - News) and privately held BioHelix have announced today that they have entered into a non-exclusive worldwide license and supply agreement for BioHelix's proprietary Helicase Dependent Amplification technology (HDA). HDA is a versatile assay technology to detect and analyze...Wed, 30 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94371&full=1ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ - News) today announced U.S. launch of the TigerWire Steerable Guidewire. The newest member of the St. Jude Medical GuideRight family of steerable guidewires, the TigerWire Steerable Guidewire is designed to enhance physicians ability to steer through challenging peripheral arteries, the vessels that supply blood to the legs and...Wed, 30 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94208&full=1PENZBERG, Germany--(BUSINESS WIRE)--Roche Diagnostics and BIOTECON Diagnostics GmbH, Potsdam , Germany, have entered into a licensing agreement concerning Roches LightCycler system technology. Under the terms of the agreement, Roche grants a non-exclusive worldwide license to BIOTECON authorizing them to develop, produce, and sell kits in the food and GMO (Genetically Modified Organisms) analysis...Tue, 29 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94268&full=1MEMPHIS, Tenn. & MARTINSREID, Germany--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) and Scil Technology GmbH today announced a development, licensing and supply agreement between Medtronic and Scil Technology. The agreement focuses on development of Scils biologic rhGDF-5 (recombinant human Growth and Differentiating Factor 5) dental regenerative technology for use in bone regeneration for dental...Tue, 29 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94214&full=1PARIS--(BUSINESS WIRE)--Sorin Group (MIL:SRN) Cardiac Rhythm Management announced today the first implant in a clinical trial of its new-generation PARADYM 8770 sonR1 cardiac resynchronization therapy defibrillator (CRT-D). This system contains a unique technology named sonR designed to adjust CRT delivery based on hemodynamic response as opposed to conventional CRT-D devices, that monitor the electrical...Tue, 29 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94191&full=1WALTHAM, Mass.--(BUSINESS WIRE)--NeuroMetrix, Inc. (Nasdaq: NURO) today announced that it has received 510(k) clearance for its ADVANCE System (ADVANCE) from the U.S. Food and Drug Administration (FDA). This regulatory determination by the FDA gives NeuroMetrix clearance to market ADVANCE in the U.S. market. The device is intended to be used by physicians to perform nerve conduction studies and invasive...Tue, 29 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94315&full=1<p> BURLINGTON, Mass., April 29 /PRNewswire/ -- InfraReDx, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its catheter-based LipiScan(TM) Coronary Imaging System. The LipiScan device uses near-infrared spectroscopy to identify lipid core containing plaques of interest in the coronary arteries in patients already undergoing cardiac...Tue, 29 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94328&full=1New kit sizes offered for spinal fusion and dental regenerative procedures</p><p>MEMPHIS, Tenn.--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) today announced it has received approval to market two smaller kit sizes of INFUSE Bone Graft for use in certain spinal fusion and dental regenerative procedures. The U.S. Food and Drug Administration (FDA) has approved two additional configurations of INFUSE...Tue, 29 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94247&full=1<p> WESTFORD, Mass., April 29 /PRNewswire-FirstCall/ -- Cynosure, Inc. , a leading developer and manufacturer of a broad array of light-based aesthetic treatment systems, today announced record revenues and gross margin for the quarter ended March 31, 2008.</p><p> First-Quarter 2008 Financial Results</p><p> Revenues increased approximately 41% to a record $36.8 million in the first quarter...Tue, 29 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94309&full=1OCEANSIDE, Calif.--(BUSINESS WIRE)--International Stem Cell Corporation (OTCBB: ISCO) announced today that it has entered into an exclusive agreement with CellSystems Biotechnologie to distribute laboratory-cultured models of human skin useful for testing the hazardous properties of consumer products and for dermatological and pharmaceutical research. Such testing is likely to be soon required for...Tue, 29 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94099&full=1MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT - News) today announced that the FDA has cleared the OneTouch UltraLink Meter as the new wireless meter exclusively certified by Medtronic to wirelessly communicate with Medtronic diabetes management products in the United States. This new meter uses Medtronic-certified wireless technology to transmit glucose readings directly to MiniMed Paradigm...Mon, 28 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94076&full=1EATONTOWN, N.J., April 25 /PRNewswire-FirstCall/ -- Osteotech, Inc. (Nasdaq: OSTE - News), a leader in the emerging field of biologic solutions for regenerative medicine, announced today that the United States Food and Drug Administration ("FDA") has cleared its 510(k) submission for the Plexur P(TM) Biocomposite for use in spinal applications as a bone void filler and as a bone graft extender. Previously...Mon, 28 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94163&full=1IRVINE, Calif.--(BUSINESS WIRE)--Nihon Kohden America, Inc. has announced that its Prefense Early Detection and Notification System has received 510K clearance from the U.S. Food & Drug Administration, paving the way for immediate release to customers.</p><p>Prefense, the worlds first Early Detection and Notification System is designed to protect hospital patients from medical harm and enhance...Mon, 28 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94064&full=1PRINCETON, N.J., April 28 /PRNewswire-FirstCall/ -- Derma Sciences (OTC Bulletin Board: DSCI - News), a provider of advanced wound care products, today announced that the FDA has given clearance to another dressing in the MEDIHONEY(TM) product line. This dressing is the first 100% medical grade honey product cleared for use on burns and wounds by the FDA. The product is 100% Active Leptospermum Honey...Mon, 28 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94110&full=1BERKELEY, Calif.--(BUSINESS WIRE)--Both PTG and DSM believe that innovative biomaterials will become enabling technology for tomorrows medical devices and prosthetic implants. This union creates a world-class organization committed to advancing biomaterials science and engineering for the benefit of patients around the world. This is great news for PTGs customers and for the medical device industry...Mon, 28 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94063&full=1NEW YORK, April 28 (Reuters) - A unit of Medtronic Inc has reached agreement on a consent decree with the U.S. Food and Drug Administration about quality system improvements for external defibrillator products, the company said on Monday.Mon, 28 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94070&full=1RESEARCH TRIANGLE PARK, N.C., April 28 /PRNewswire/ -- Tryton Medical, Inc. announced today that it has appointed J. Greg Davis as President and Chief Executive Officer. Founded in 2003, Tryton Medical is the leading developer of stents that are designed to definitively treat bifurcation lesions.</p><p>Mr. Davis joins Tryton Medical after a successful 20-year career with Guidant and Eli Lilly ...Mon, 28 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94072&full=1SAN CLEMENTE, Calif.--(BUSINESS WIRE)--VertiFlex, Inc., a private spinal technology company, today announced it has named Earl R. Fender President and Chief Executive Officer and Member of the Board of Directors.</p><p>Mr. Fender brings over 25 years of successful leadership experience in general management and product commercialization in the medical device and spinal industry. During a 10 year...Mon, 28 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94067&full=1NEW YORK--(BUSINESS WIRE)--DynaMed Systems, LLC announced today that the U.S. Food and Drug Administration (FDA) has approved its investigational Device Exemption (IDE) Application to study the Traxon Spinal Cord Repair Stimulation System (TRAXON System) in acute spinal cord injured patients. The study is designed to assess the safety and effectiveness of the TRAXON System, a surgically implanted...Mon, 28 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=94003&full=1LITTLE FALLS, N.J.--(BUSINESS WIRE)--CANTEL MEDICAL CORP. (NYSE:CMN) announced the resignation of President and CEO R. Scott Jones, effective as of Tuesday, April 22, 2008. Concurrently, the Board created the Office of the Chairman and promoted COO and Executive Vice President Andrew A. Krakauer to President and a member of the Office of the Chairman. The newly created Office of the Chairman will include...Fri, 25 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93929&full=1HARBIN, China, April 24 /Xinhua-PRNewswire-FirstCall/ -- China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (OTC Bulletin Board: CSKI - News), a pharmaceutical company for external use over-the-counter drugs in the People's Republic of China ("PRC"), today announced it acquired Heilongjiang Haina Pharmaceutical Inc. ("Haina Pharmaceutical"), a recently formed corporation organized...Fri, 25 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93927&full=1PLAINSBORO, N.J., April 25, 2008 (PRIME NEWSWIRE) -- Integra LifeSciences Holdings Corporation (NasdaqGS:IART - News) announced today the release of the LimiTorr(TM) Volume Limiting CSF Drainage System, the latest addition to Integra's cerebral spinal fluid (CSF) drainage product line and the first volume-limiting CSF management system on the market. The LimiTorr(TM) system was designed with the help...Fri, 25 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93935&full=1<p> SEATTLE, April 25 /PRNewswire-FirstCall/ -- VentriPoint(TM) Diagnostics Ltd. today announced that it has finalized a research and technology development agreement with the University of Washington to collaborate on projects that will enhance and broaden the VentriPoint Diagnostic System (VDS) commercial offering.</p><p> Under the terms of the agreement, the University of Washington will...Fri, 25 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93950&full=1<p> LOGAN, Utah, April 25 /PRNewswire/ -- Facet Solutions, Inc. announced today the addition of Dr. Marc Peterman to its executive management team. Dr. Peterman will serve as Vice President of Research and Development for Facet Solutions, bringing with him a long history of spine system/orthopedic development experience, most recently having directed development activities at Abbott Spine.</p>...Fri, 25 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93928&full=1EAST HILLS, N.Y.--(BUSINESS WIRE)--Donald Stevens has been named Pall Corporation (NYSE:PLL - News) president according to an announcement today by Eric Krasnoff, chairman and CEO. Mr. Krasnoff held the title prior to Mr. Stevens' promotion.</p><p>Mr. Stevens, 63, has spent substantially his entire career with Pall. He heads the company's Industrial business which accounts for 60% of total revenues...Fri, 25 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93767&full=1CARLSBAD, Calif., April 24, 2008 (PRIME NEWSWIRE) -- Alphatec Holdings,Inc. (Nasdaq:ATEC), a medical technology company focused on the design,development, manufacturing and marketing of products for the surgicaltreatment of spine disorders, announced today that Alphatec andScient'x, S.A. have mutually terminated Alphatec's license fromScient'x of intellectual property related to the DYNAMO...Thu, 24 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93798&full=1<p> PLANO, Texas, April 22 /PRNewswire-FirstCall/ -- Perot Systems Corporation and Surgical Care Affiliates (SCA) today announced an agreement in which Perot Systems will implement advanced technology solutions to serve as a catalyst for business growth. Through this agreement, Perot Systems will help SCA improve support for its more than 2,000 physician partners and 130 outpatient surgery centers...Thu, 24 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93802&full=1<p> MARICOPA, Ariz., April 24 /PRNewswire/ -- Yulex Corporation, a company that produces natural rubber found to be safe for medical devices, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the first medical device made from guayule, a desert crop native to the U.S. Southwest. The examination gloves made with patented Yulex(R) natural rubber, and cleared by the...Thu, 24 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93770&full=1SCOTTSDALE, Ariz.--(BUSINESS WIRE)--ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB:IRBO - News), today announced an agreement with BioCure, Inc., to design and develop a novel wound-healing product. Under the recently executed Material Transfer Agreement (MTA), BioCure will utilize ImmuneRegens Homspera for the development of a combination product...Thu, 24 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93763&full=1INVERNESS, Scotland, April 24 /PRNewswire-FirstCall/ - In Veritas announces that it has secured a fundamental balance sheet restructuring leaving it free of all loan note indebtedness, and that it has secured a further equity capital line to enable it to move forward. The Company has been frustrated under the pressure of excessive debt since late 2005.</p><p>Medical Diagnostic Innovations Ltd...Thu, 24 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93621&full=1MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT - News) and Restore Medical, Inc. (NASDAQ: REST - News) today announced that the companies have signed a definitive agreement under which Medtronic will pay $1.60 per share in cash for each share of Restore Medical stock. The total value of the transaction, including payment of Restore Medical debt will be approximately $29 million. The transaction...Wed, 23 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93633&full=1ABBOTT PARK, Ill., April 22 /PRNewswire-FirstCall/ -- A study published in today's Journal of the American Medical Association (JAMA) demonstrated that use of Abbott's XIENCE(TM) V Everolimus Eluting Coronary Stent System in patients with coronary artery disease resulted in a significant 50 percent reduction in vessel renarrowing (in-segment late loss) at eight months, non-inferior rates of target...Wed, 23 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93616&full=1SAN JOSE, Calif. & ALPHARETTA, Ga.--(BUSINESS WIRE)--Micrus Endovascular Corporation (Nasdaq:MEND - News) and privately held Chemence Medical Products, Inc. today announced the signing of an exclusive agreement to jointly develop liquid embolic products for neurovascular indications using Chemences cyanoacrylate technology, development capabilities and intellectual property. Micrus Endovascular will...Wed, 23 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93641&full=1<p> SUNNYVALE, Calif., April 23 /PRNewswire/ -- Starion Instruments, a leading surgical device company, today announced that the State Food and Drug Administration (SFDA) of the People's Republic of China has granted regulatory approval for the sale of Starion's patented Tissue Welding technology in China. This approval marks a significant milestone in Starion's continued worldwide expansion....Wed, 23 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93618&full=1SAN CARLOS, Calif.--(BUSINESS WIRE)--NuGEN Technologies, Inc., a privately held company that develops and commercializes nucleic acid amplification and labeling systems, announced today that it has been awarded the International Standards Organizations 13485:2003 certification by TUV SUD, an engineering services firm providing international safety testing and certification services.</p><p>ISO...Wed, 23 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93617&full=1AUSTIN, Texas--(BUSINESS WIRE)--Asuragen, Inc. announced today the launch of the first microRNA (miRNA) test for clinical diagnosis and disease management. The assay utilizes qRT-PCR technology* and differentiates between chronic pancreatitis and pancreatic cancer (pancreatic ductal adenocarcinoma). Pancreatic cancer is the 4th leading cause of cancer related deaths in the United States. Chronic pancreatitis...Wed, 23 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93558&full=1Also Announces Intention to Effect Private Placement of Common Stock </p><p>TORONTO, ONTARIO--(Marketwire - April 22, 2008) - OccuLogix, Inc. (NASDAQ: OCCX)(TSX: OC) announced today that it has signed a definitive merger agreement to acquire the minority ownership interest in San Diego-based OcuSense, Inc. that it does not already own. Currently, OccuLogix owns 50.1% of the capital stock of OcuSense...Tue, 22 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93445&full=1HOUSTON--(BUSINESS WIRE)--IDev Technologies, Inc., an emerging leader in the development and marketing of minimally invasive stent systems for the treatment of peripheral vascular and non-vascular diseases, today announced that it has closed a $25 million Series C round of financing. The financing was secured entirely by existing investors which include: PTV Lifesciences, Rivervest Venture Partners...Tue, 22 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93450&full=1PLEASANTON, Calif., April 21 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR - News), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that it has received FDA approval of its PMA (PreMarket Approval) application, allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) as a bridge-to-transplantation...Tue, 22 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93451&full=1DANVERS, Mass.--(BUSINESS WIRE)--NeuroLogica Corporation announced that it will acquire all technology and assets for Xenon CT Perfusion from Diversified Diagnostic Products Inc. The combination of Portable CT and Xenon CT Perfusion, will now allow faster, more accurate and quantifiable information on cerebral blood flow in patients with a variety of neurological emergencies such as stroke and traumatic...Tue, 22 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93441&full=1PHOENIX--(BUSINESS WIRE)--Zila, Inc. (NASDAQ:ZILA - News) today announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market ViziLite Eyewear. ViziLite Eyewear is reusable filtered eyewear to be worn by a health care professional to eliminate ambient light while performing an oral exam under chemiluminescence when a darkened room is not available....Tue, 22 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93448&full=1CARSON CITY, Nev.--(BUSINESS WIRE)--VitalCare Diabetes Treatment Centers, Inc. (NASDAQ: VDTI - News), a Nevada Corporation, today announced the FDA approval (called allowance to market) exists for the infusion devices used by VitalCare for its Intracellular Activation Therapy (iCAT) treatment of Type 1 and Type 2 diabetes. Jimmy McDougald, CEO stated, stated, This is a major factor in the establishment...Tue, 22 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93437&full=1SUNNYVALE, Calif., April 22 /PRNewswire/ -- Pathwork Diagnostics, Inc., a genomics-based diagnostics company focused on oncology, today announced the launch of the Pathwork Tissue of Origin Test through its CLIA-certified Pathwork Diagnostics Laboratory. The new test aids in the diagnosis of tumors of uncertain origin and is among the first microarray-based diagnostic tests for cancer available in...Tue, 22 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93288&full=1VANCOUVER, April 21 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced that it has elected to suspend enrolment in its U.S. and EU human clinical trials for its Vascular Wrap product candidate in patients undergoing surgery for hemodialysis access, pending a safety review to evaluate an imbalance...Mon, 21 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93298&full=1SAN DIEGO--(BUSINESS WIRE)--Artes Medical, Inc. (Nasdaq: ARTE - News), a medical technology company whose product ArteFill is the first and only FDA-approved, non-resorbable injectable dermal filler for the correction of smile line wrinkles, today reported that it has initiated a plan to significantly reduce certain administrative and operating costs to re-align the Companys overall cost structure...Mon, 21 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93296&full=1VANCOUVER, April 18 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today reported that its corporate partner, Boston Scientific Corporation "BSC" (NYSE: BSX - News) has received approval for the sale of its TAXUS Liberte paclitaxel-eluting coronary stent system in Canada. BSC reported that Health Canada...Mon, 21 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93291&full=1CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS - News) announced today that the Company has received expanded label claims for use of platelets and plasma treated with the INTERCEPT Blood System to prevent transfusion-associated graft-vs.-host disease (TA-GVHD) in at-risk patients. While TA-GVHD is a rare disorder, prevention is critical because it is a condition with greater than...Mon, 21 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93294&full=1BERLIN and SEATTLE, April 21, 2008 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX.F - News), a molecular diagnostics company focusing on the development and commercialization of products for cancer based on DNA methylation, today announced that it successfully validated a technically improved assay and an enhanced testing algorithm for its colorectal cancer biomarker, Septin 9, in two independent...Mon, 21 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93300&full=1GRAND RAPIDS, MI--(MARKET WIRE)--Apr 18, 2008 -- Oncologix Tech, Inc. (OTC BB:OCLG.OB - News) announced today that a non-binding Memorandum of Understanding had been signed by Oncologix and Institut fr Unwelttechnologien GmbH (IUT), a German company, for the continued development and commercialization of the Oncologix Oncosphere product. The Memorandum contemplates the formulation of a mutually agreed...Mon, 21 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93242&full=1Potsdam, Germany, April 15, 2008 / b3c newswire / - In order to enhance the worldwide launch of its innovative food safety testing systems, BIOTECON Diagnostics has formed a strategic marketing alliance with the globally operating MERCK KGaA, Darmstadt, Germany. Merck KGaA sells the foodproof range which has been available in almost all countries of the world since January 1, 2008. More new products...Fri, 18 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93228&full=1MADISON, Wis.--(BUSINESS WIRE)--TomoTherapy Incorporated (NASDAQ: TOMO), maker of the HiArt treatment system for advanced radiation therapy, announced today that it has entered into an agreement to acquire privately held linear accelerator manufacturer Chengdu Twin Peak Accelerator Technology Inc., based in Chengdu, China.</p><p>A linear accelerator (linac) is a key component in radiation therapy...Fri, 18 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93179&full=1BARCELONA, Spain--(BUSINESS WIRE)--Before the 18th European Congress of Clinical Microbiology and Infectious Disease (ECCMID) opening here tomorrow, Bruker Daltonics announces that it has received EN ISO 13485 certification for its German operations. This ISO 13485 certification is an important milestone in the development of the Bruker Daltonics in vitro diagnostics (IVD) business, particularly in...Fri, 18 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93190&full=1CHATSWORTH, Calif.--(BUSINESS WIRE)--IRIS INTERNATIONAL, INC. (NASDAQ GM: IRIS), a leading developer and manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, today announced that, having met all of the requirements, its iChemVELOCITY fully automated urine chemistry analyzer is now CE-Marked for distribution in the European...Fri, 18 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93196&full=1WOBURN, Mass., April 18 /PRNewswire/ -- VisEn Medical, Inc., a leader in fluorescence in vivo imaging, today announced the expansion of its Series B financing. Merck Capital Ventures and Flagship Ventures co-led this $5.0 million expansion of the Series B round, which initially raised $7 million in November 2007, bringing the total Series B financing amount to $12.0 million. VisEn will use the additional...Fri, 18 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93232&full=1PROVIDENCE The R.I. Economic Development Corporation announced today that Concordia Manufacturing LLC will be expanding into Warwick with the help of $500,000 in financing from the states Small Business Loan Fund.Fri, 18 Apr 2008 12:00:00 AM GMThttp://www.devicespace.com/news_story.aspx?StoryID=93270&full=1April 18, 2008 -- Calypte Biomedical Corporation (OTCBB: CBMC) of Portland, OR received SFDA approval for its oral HIV diagnostic test, Aware HIV-1/2 OMT (oral fluid). The test delivers results in 20 minutes with an accuracy comparable to lab tests. Aware is the only rapid oral fluid test approved for use in China. The test is being positioned as an alternative HIV test for medical sites that do not...Fri, 18 Apr 2008 12:00:00 AM GMT