http://www.biospace.comBioSpace RSS GeneratorWed, 22 May 2013 10:51:38 GMT20http://rss.biospace.com/images/BSPLogo.gifhttp://www.BioSpace.com/news.aspx?SectionId=1Copyright (C) 2011http://www.biospace.com/news_story.aspx?StoryID=297164&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br><div id"releaseBody"><p>ST. PAUL, MN--(Marketwired - May 17, 2013) - EnteroMedics Inc. (NASDAQ: <a href"http://www.marketwire.com/mw/stock.jsp?TickerETRM">ETRM</a>), the developer of medical devices...Fri, 17 May 2013 12:00:00 AM GMThttp://www.bizjournals.com/stlouis/blog/BizNext/2013/05/inx-medical-raises-700000-submits.htmlStaying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>Inx Medical LLC, a medical device startup, today submitted its application with the Food and Drug Administration for a new device used to aid in the surgical removal of hemorrhoids. Inx Medical President and...Thu, 09 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=295453&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br> <div class"xn-content"><p><span class"xn-location">CINCINNATI</span>, <span class"xn-chron">May 3, 2013</span> /PRNewswire/ -- Sedasys, a Division of Ethicon Endo-Surgery, Inc. (Ethicon), today announced...Mon, 06 May 2013 12:00:00 AM GMThttp://www.nasdaq.com/article/allergans-dermal-filler-juvederm-voluma-gets-fda-panel-backing-20130502-01930Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>The FDA's General & Plastic Surgery Devices advisory panel votes unanimously that the benefits outweigh the risks for aesthetic medical device maker Allergan's Juvederm Voluma XC injectable gel. An FDA...Fri, 03 May 2013 12:00:00 AM GMThttp://www.thestreet.com/story/11909450/1/fda-tells-delcath-no-approval-without-new-clinical-trial.html?cm_ven=GOOGLENStaying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>Delcath Systems, which is moving its headquarters from Manhattan to Queensbury, NY, could be forced to conduct another clinical trial before it receives approval from the U.S. Food and Drug Administration...Wed, 01 May 2013 12:00:00 AM GMTStaying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>SOUTH SAN FRANCISCO, CA--(Apr 30, 2013) - Titan Pharmaceuticals, Inc. (OTCBB: TTNP) announced that the U.S. Food and Drug Administration (FDA) has issued this evening a Complete Response Letter (CRL) to...Wed, 01 May 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130424005544&newsLang=enStaying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ: CERS) announced today that the U.S. Food and Drug Administration (FDA) has accepted its proposed modular Premarket Approval (PMA) application shell...Wed, 24 Apr 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20130416006446&newsLang=enSALT LAKE CITY--(BUSINESS WIRE)--BioFire Diagnostics, Inc. today announced that it has submitted the FilmArray Blood Culture Identification (BCID) Panel to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. The submission comes after the successful completion of clinical trials for the FilmArray BCID Panel. The panel provides automatic results for the most common infectious causes of...Wed, 17 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=293428&full=1<div class"xn-content"><p><span class"xn-location">SAN DIEGO</span>, <span class"xn-chron">April 16, 2013</span> /PRNewswire/ -- <b>Aethlon Medical, Inc.</b> (OTCQB: AEMD), today released the following note authored by its Chairman and CEO, <span class"xn-person">Jim Joyce</span>.</p><p>As disclosed in yesterday's SEC form 8-K submission, we entered into a subcontract agreement with Battelle Memorial...Tue, 16 Apr 2013 12:00:00 AM GMThttps://www.massdevice.com/news/breaking-fda-panel-recommends-approval-bausch-lombs-trulign-toric-eye-implantAn FDA advisory panel votes to recommend approval for the Trulign Toric, Bausch Lomb's first-of-a-kind intraocular lens for patients who have had a cataract removed. An FDA advisory panel agreed today to recommend that the federal watchdog agency approve Bausch Lomb's first-of-a-kind intraocular lens for patients who have had a cataract removed and would like to, without glasses, have improved...Tue, 09 Apr 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20130402005518&newsLang=enCAMBRIDGE, Mass.--(BUSINESS WIRE)--Seventh Sense Biosystems, a privately held medical device company developing integrated blood micro-collection and analysis platforms, announced today that it has initiated a registration trial for its painless TAP (Touch Activated Phlebotomy) blood collection device. The company expects to file for marketing authorization in the United States and in the European...Tue, 02 Apr 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130329005028&newsLang=enCHALFONT ST. GILES, England--(BUSINESS WIRE)--GE Healthcare today announced that it has submitted an application to amend its European Marketing Authorisation that will allow the company to manufacture Optison 0.19 mg/ml dispersion for injection within its own facility. Upon approval, GE Healthcare will provide supply of Optison to the EU market from its manufacturing facility in Oslo, Norway. Fri, 29 Mar 2013 12:00:00 AM GMThttps://www.massdevice.com/news/psivida-takes-another-stab-fda-approval-iluvienAs pSivida gears up to begin distribution of its Illuvien eye treatment in Europe, it plans to re-submit its new drug application to the FDA for the drug/device combination. It's been a rocky road for pSivida's (NSDQ:PSDV) Illuvien, a drug/device combination for macular degeneration, but the company hopes that new trial data will pave the way to regulatory approval in the U.S.Wed, 27 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291260&full=1 BOSTON and MUMBAI, India, March 21, 2013 -- /PRNewswire/ -- Piramal Imaging SA, a division of Piramal Enterprises, today announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted its applications for review of the investigational PET amyloid imaging agent [18F] florbetaben. A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration...Thu, 21 Mar 2013 12:00:00 AM GMThttp://www.reuters.com/article/2013/03/18/us-abbott-fda-mitralvalvedevice-idUSBRE92H0JZ20130318Staff reviewers for the Food and Drug Administration did not recommend the approval of Abbott Laboratories' implantable heart device MitraClip, citing a lack of "valid scientific evidence" of safety and effectiveness. FDA reviewers said in briefing documents, posted on the regulator's website on Monday, that approval of the device would not be appropriate at the time as major questions of safety, efficacy...Tue, 19 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=289827&full=1<div class"xn-content"><p><span class"xn-location">TORONTO</span>, <span class"xn-chron">March 7, 2013</span> /PRNewswire/ -- CellAegis Devices, Inc. announced today that it has received marketing authorization from Health Canada that allows for the commercial introduction in <span class"xn-location">Canada</span> of the Company's autoRIC Device for Remote Ischemic Conditioning (RIC). Health Canada...Thu, 07 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=288320&full=1Berlin, Germany, and Seattle, WA, U.S.A., February 21, 2013 - Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, announced today that the United States Food & Drug Administration (FDA) accepted its Premarket Approval (PMA) application for Epi proColon. The agency concluded that all information needed for the substantive review is included...Thu, 21 Feb 2013 12:00:00 AM GMThttp://www.globenewswire.com/news-release/2013/02/01/520311/10020256/en/EDAP-Submits-U-S-FDA-Pre-Market-Approval-Application-for-Ablatherm-R-HIFU-for-Treatment-of-Low-Risk-Localized-Prostate-Cancer.htmlLYON, France, Feb. 1, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today the submission of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) on January 31, 2013 for the Company's Ablatherm-HIFU (High Intensity Focused Ultrasound) for treatment of low risk, localized prostate cancer. EDAP's PMA submission...Fri, 01 Feb 2013 12:00:00 AM GMThttp://www.forbes.com/sites/jenniferhicks/2013/01/29/first-bionic-eye-for-us-market-awaits-approval-from-fda/The retina is the back part of your eye with the cells that respond to light. The cells are known as photo receptors and come in two varieties: rods and cones. Rods are very sensitive to light, shapes and movements and cones are not as sensitive, but they control the perception of color. Like a digital camera, the retina does basic optical processing like edge detection and enhancement and color separation...Tue, 29 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=285110&full=1<div class"xn-content"><p><span class"xn-location">ATLANTA</span>, <span class"xn-chron">Jan. 17, 2013</span> /PRNewswire/ -- Alimera Sciences, Inc., (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced the Spanish Agency of Drugs and Medical Devices (Agencia Espanola...Thu, 17 Jan 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20130108005396&newsLang=enPRINCETON, N.J.--(BUSINESS WIRE)--GE Healthcare today announced that regulatory bodies in the United States and Europe have accepted its applications for review of the investigational PET amyloid imaging agent [18F]flutemetamol, a positron emission tomography (PET) imaging agent. A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) for [18F]flutemetamol use in the...Tue, 08 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=284058&full=1Berlin, Germany, and Seattle, WA, U.S.A., January 7, 2013 - Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, announced today that it has submitted the fourth and final module of its Premarket Approval (PMA) to the United States Food & Drug Administration (FDA) for its blood-based Epi proColon test for the detection of colorectal cancer...Mon, 07 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=283619&full=1<div class"xn-content"><p><span class"xn-location">SAN DIEGO</span>, <span class"xn-chron">Jan. 3, 2013</span> /PRNewswire/ --<b> Aethlon Medical, Inc.</b> (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, disclosed today that it has submitted an Investigational Device Exemption (IDE) to...Thu, 03 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=283019&full=1CASTLE ROCK, Colo.</span>, <span class"xn-chron">Dec. 21, 2012</span> /PRNewswire/ -- <b>Venaxis, Inc.</b> (Nasdaq: APPY), an <i>in vitro</i> diagnostic company, today announced it has filed for CE Mark approval in <span class"xn-location">Europe</span> for APPY1, the Company's blood-based appendicitis test. Based upon the standard protocol for submission of its technical file for APPY1 through...Fri, 21 Dec 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20121213005366&newsLang=enCONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ: CERS) announced today that the U.S. Food and Drug Administration (FDA) has accepted its proposed modular Premarket Approval application (PMA) shell for review of the INTERCEPT Blood System for plasma. A PMA shell is an outline of the application process that defines the structure, content and timing of each module. FDA and the applicant need...Thu, 13 Dec 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20121210006286&newsLang=enMADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (Nasdaq: EXAS) today announced that it has submitted to the U.S. Food and Drug Administration the first module of the premarket approval (PMA) application for its stool DNA colorectal cancer screening test. This module was comprised of the required documentation regarding the manufacturing and quality control systems for the product. The modules...Tue, 11 Dec 2012 12:00:00 AM GMTSAN LUIS OBISPO, Calif.--(BUSINESS WIRE)--FzioMed, a privately held medical device company based in San Luis Obispo, CA, has filed a petition for reconsideration with the U.S. Food and Drug Administration, under Section 515(g)(2)(a) of the Food Drug Cosmetic Act, Section 562 of the FD&C act and Part 10.33 of Title 21 Code of Federal regulations, which denied approval of its premarket approval application...Fri, 07 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=280678&full=1<div id"releaseBody"><p>YOQNEAM, ISRAEL--(Marketwire - November 27, 2012) - Given Imaging Ltd (NASDAQ: <a href"http://www.marketwire.com/mw/stock.jsp?TickerGIVN">GIVN</a>), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that it has filed a U.S. Food and Drug Administration (FDA) application seeking regulatory clearance to market its PillCam&#174; COLON...Tue, 27 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=280438&full=1<div id"releaseBody"><p>EDEN PRAIRIE, MN and SYDNEY, AUSTRALIA--(Marketwire - November 20, 2012) - Sunshine Heart, Inc. (NASDAQ: <a href"http://www.marketwire.com/mw/stock.jsp?TickerSSH">SSH</a>) (ASX: SHC), a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced it has received unconditional approval from the FDA to commence its...Wed, 21 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=280174&full=1<div class"xn-content"><p><span class"xn-location">FRAMINGHAM, Mass.</span>, <span class"xn-chron">Nov. 19, 2012</span> /PRNewswire/ -- Dune Medical Devices, Inc., announced today that it has received an Approvable Letter for its Premarket Approval Application (PMA) from the Food and Drug Administration. The Approvable Letter states that the MarginProbe System PMA is approvable subject to final...Mon, 19 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=279017&full=1 <div class"xn-content"><p><span class"xn-location">SARATOGA, Calif.</span>, <span class"xn-chron">Nov. 8, 2012</span> /PRNewswire/ -- VisionCare Ophthalmic Technologies, Inc., developer of the first FDA-approved ophthalmic telescope implant indicated to improve vision in patients with end-stage age-related macular degeneration (AMD), announced today it has received a Health Canada Medical Device...Thu, 08 Nov 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.b30484b92e958b11adda3242e6908a0c/index.jsp?ndmViewId=news_view&newsId=20121106005090&newsLang=enCAMBRIDGE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. today announced that it has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its Paragonix Sherpa Pak Cardiac Transport System1,2(CTS). The Sherpa Pak CTS is indicated for the static hypothermic preservation of hearts during transportation and eventual...Tue, 06 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=277745&full=1<div class"xn-content"><p><span class"xn-location">PITTSBURGH</span>, <span class"xn-chron">Oct. 30, 2012</span> /PRNewswire/ -- Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received approval from the United States Food and Drug Administration ("FDA") for the first of four modules of the Company's PMA...Tue, 30 Oct 2012 12:00:00 AM GMThttp://www.massdevice.com/news/breast-cancer-fda-panel-votes-expand-pma-hologics-mammography-systemThe FDA's Radiological Devices Panel votes to approve expanded indication for Hologic's Selenia 3D digital mammography system.<br><br>The FDA's Radiological Devices Panel this week voted to grant Hologic's (NSDQ:HOLX) expanded approval for its 1st-of-its-kind Selenia Dimensions 3D digital mammography system.Mon, 29 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=277482&full=1<div id"releaseBody"><p>SAN DIEGO, CA--(Marketwire - October 26, 2012) - NuVasive, Inc. (NASDAQ: <a href"http://www.marketwire.com/mw/stock.jsp?TickerNUVA">NUVA</a>), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for the PCM...Fri, 26 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=276854&full=1AUSTIN, TX October 22, 2012 On-X Life Technologies, Inc. (On-X LTI) announced today that it has submitted applications for review and approval to the United States Food and Drug Administration (USFDA) and to the Conformit Europenne (CE) with new Instructions for Use (IFU) that recommend use of the On-X Aortic Valve at reduced levels of anticoagulation. The applications were submitted based upon...Mon, 22 Oct 2012 12:00:00 AM GMThttp://www.bizjournals.com/albany/news/2012/10/16/delcath-clears-important-fda-hurdle.html?ana=otjrssThe Business Review by Barbara Pinckney, Reporter </p><p>Delcath Systems Inc. is calling the U.S. Food and Drug Administrations acceptance of its new drug application a significant milestone, although it came with some disappointment.</p><p>The New York City-based medical device company, which has research and manufacturing operations in Queensbury, New York, submitted the NDA in mid-August...Wed, 17 Oct 2012 12:00:00 AM GMThttp://www.massdevice.com/news/fda-panel-review-coaxias-neuroflo-catheterThe FDA's Neurological Devices Panel will next month review CoAxia's NeuroFlo catheter for treatment of cerebral ischemia. Privately held CoAxia Inc. landed a date with the FDA's Neurological Devices Panel to submit its NeuroFlo catheter for de novo approval. The Minneapolis-based company's NeuroFlo device, which already has CE Marking for the European Union, aims to divert blood flow in the brain...Fri, 12 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=275019&full=1 <div class"xn-content"><p /><p /><p><span class"xn-location">SEVERNA PARK, Md.</span>, <span class"xn-chron">Oct. 3, 2012</span> /PRNewswire/ -- Medical technology company iSonea Ltd. (ASX: <a href"http://www.asx.com.au/asx/research/companyInfo.do?byasxCode&amp;asxCodeISN" target"_blank">ISN</a>; OTCQX: <a href"http://www.otcmarkets.com/stock/ISOAY/quote" target"_blank">ISOAD</a>) today announced...Wed, 03 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=274546&full=1SYLMAR, Calif.--(BUSINESS WIRE)-- On Friday September 28th, a U.S. Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel unanimously voted 19-0 that the probable benefit of the Argus II Retinal Prosthesis System outweighs the risks to health, an important step toward the FDA market approval of this product manufactured by Second Sight Medical Products, Inc. In making this determination...Mon, 01 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=274579&full=1<div id"releaseBody"><p>EDEN PRAIRIE, MN and SYDNEY, AUSTRALIA--(Marketwire - October 01, 2012) - <b> </b>Sunshine Heart, Inc. (NASDAQ: <a href"http://www.marketwire.com/mw/stock.jsp?TickerSSH">SSH</a>) (ASX: SHC), a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced that it has received conditional approval from the FDA for...Mon, 01 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=274275&full=1QUBEC CITY, QC, <span class"xn-chron">Sept. 26, 2012</span> /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that it continues to expect to file a New Drug Application (NDA) early next year, for its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency (AGHD), after receiving notification from the United States...Wed, 26 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=273982&full=1SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Dallen Medical of San Clemente has filed its FDA 510(k) application for the Compressyn staple for small bone fixation, specifically in foot, ankle, and hand applications. With the companys Compressyn band for sternal closure already FDA cleared, this application is part of the companys plan to expand its Compressyn family of products.</p><p>We are very...Tue, 25 Sep 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace2/template.PAGE/menuitem.ce58e8202d51f40bfcb16f10c0908a0c/index.jsp?ndmViewId=news_view&newsId=20120919006941&newsLang=enSHANGHAI--(BUSINESS WIRE)--Responding to predicted growth in Chinas medical industry, Bal Seal Engineering, Inc., a leading provider of custom-engineered sealing, connecting, conducting and EMI shielding components, has added a new territory manager to its Asia Pacific sales team. Michael Wong, a degreed mechanical engineer, joined Bal Seal earlier this summer as its third territory manager in the...Thu, 20 Sep 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20120918005906&newsLang=enPORTLAND, Ore. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--MolecularMD Corp. and ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that MolecularMD has voluntarily withdrawn its Premarketing Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its BCR-ABL T315I Mutation Test. The test detects the BCR-ABL T315I mutation in chronic myeloid leukemia (CML) and Philadelphia-chromosome...Tue, 18 Sep 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/09/10/us-navidea-fda-lymphoseek-idUSBRE88919E20120910Business First by Carrie Ghose, Staff reporter </p><p>The U.S. Food and Drug Administration late Monday declined to approve sales of Navidea Biopharmaceuticals Inc.s radioactive diagnostic aid Lymphoseek, delaying the long-awaited start of sales projected in the hundreds of millions of dollars.</p><p>The FDA noted the decision was focused on issues with third-party Lymphoseek contract manufacturing...Wed, 12 Sep 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace2/template.PAGE/menuitem.ce58e8202d51f40bfcb16f10c0908a0c/index.jsp?ndmViewId=news_view&newsId=20120905005130&newsLang=enWOODMERE, N.Y.--(BUSINESS WIRE)--Nomir Medical Technologies, Inc., a leader in novel photobiology and laser therapies, announced today that the company has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the indication of temporary increase of clear nail in patients with onychomycosis (toenail fungus).Wed, 05 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=269855&full=1TORONTO, Aug. 13, 2012 /CNW/ - Biosign Technologies Inc. (TSXV: BIO) ("Biosign" or the "Company") announced today that it has filed a 510(k) premarket notification application with the United States Food & Drug Administration (FDA) for the UFIT TEN-10 Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services. The intended use of the product is for the measurement of blood pressure...Mon, 13 Aug 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=269264&full=1<div class"xn-content"><p><span class"xn-location">CASTLE ROCK, Colo.</span>, <span class"xn-chron">Aug. 7, 2012</span> /PRNewswire/ -- <b>AspenBio Pharma, Inc.</b> (Nasdaq: APPY), an <i>in vitro</i> diagnostic company, announced that it has submitted a pre-IDE (Investigational Device Exemption) information package to the U. S. Food and Drug Administration (FDA) for the use of the <i>AppyScore...Tue, 07 Aug 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=268899&full=1NEW YORK</span>, <span class"xn-chron">Aug. 2, 2012</span> /PRNewswire/ -- Philosys announced today that it has applied for approval from the U.S. Food and Drug Administration (FDA) for its Gmate <a href"http://www.gmate.com/" target"_blank">blood glucose monitoring</a> system in Q4 2011, and expects approval in third quarter 2012. The new Gmate SMART is the smallest and most innovative meter...Fri, 03 Aug 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=268352&full=1<div id"releaseBody"><p>PORTLAND, OR--(Marketwire - July 30, 2012) - <table class"releaseLink"><tr><td class"releaseLink"><b>Highlighted Links</b></td></tr><tr><td><p>&nbsp;</p><a href"http://www2.marketwire.com/mw/mmframe?prid914599&attachid2052606">Company Link</a></td></tr></table> <a href"http://www.molecularmd.com">MolecularMD</a> Corp. today announced that it has submitted its application...Tue, 31 Jul 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=267742&full=1NORCROSS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (GTHP) (GTHP) today announced that it met with the Food and Drug Administration (FDA) on July 20, 2012. The company believes the meeting was very positive and plans to work with FDA to finalize the path forward to gain premarket approval (PMA) for the LuViva Advanced Cervical Scan, a non-invasive device used to detect cervical disease that...Wed, 25 Jul 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=267743&full=1SEND, England--(BUSINESS WIRE)-- Anaxsys Ltd, the medical device company developing innovative respiratory devices, announced the filing of a 510(k) Premarket Notification with the U.S. Food and Drug Administration (FDA) for regulatory clearance for respiR8 continuous respiratory rate counter. respiR8, which monitors respiratory rates in post-operative, trauma and emergency procedure patients, has...Wed, 25 Jul 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20120709006586&newsLang=enFRANKLIN, Tenn.--(BUSINESS WIRE)--BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced today that it has submitted to the Food and Drug Administration (FDA) an amendment to its Pre-Market Approval (PMA) application for Augment Bone Graft for its use as an alternative to autograft in hindfoot and ankle fusion procedures. The amendment provides supplemental information requested by the FDA in a post...Tue, 10 Jul 2012 12:00:00 AM GMThttp://www.news-medical.net/news/20120626/Beckman-Coulter-announces-PMA-from-FDA-for-Prostate-Health-Index.aspxBREA, Calif.</span>, <span class"xn-chron">June 25, 2012</span> /PRNewswire/ -- <span class"xn-person">Beckman Coulter</span>, Inc., the leader in prostate cancer diagnostics, announces Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the Prostate Health Index (<i>phi</i>), a simple, non-invasive blood test that is 2.5-times more specific in detecting prostate cancer...Tue, 26 Jun 2012 12:00:00 AM GMThttp://www.rttnews.com/1910987/repligen-losing-ground-in-pre-market-on-fda-news.aspx?type=5u&utm_source=google&utm_campaign=sitemapWALTHAM, Mass.--(BUSINESS WIRE)-- Repligen Corporation (RGEN) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the Companys New Drug Application (NDA) for RG1068 (synthetic human secretin). RG1068 was evaluated in a Phase 3 study to improve detection of pancreatic duct abnormalities in combination with MRI in patients with...Fri, 22 Jun 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=264539&full=1CANTON, Conn., June 20, 2012 (GLOBE NEWSWIRE) -- Kelyniam Global, Inc. (KLYG), a medical device company focused on the design and manufacturing of custom cranial implants, has filed a 510(k) application with the Food and Drug Administration (FDA) for clearance to market a custom craniofacial implant product made from the Invibio PEEK Optima material. The application has been received and is currently...Wed, 20 Jun 2012 12:00:00 AM GMThttp://www.rttnews.com/1902263/roche-submits-tnt-hs-assay-for-clearance-on-cobas-immunoassay-elecsys-analyzers.aspx?type=qfINDIANAPOLIS</span></span>, <span class"xn-chron">June 7, 2012</span> /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has filed a 510(k) submission to the U.S. Food and Drug Administration (FDA) for a fully automated TnT-hs assay for use on Roche's full portfolio of laboratory analyzers.* Intended as an aid in the in the diagnosis of myocardial infarction, the electrochemiluminescence...Fri, 08 Jun 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=263084&full=1<div id"releaseBody"><p>MEDFORD, NY--(Marketwire - June 07, 2012) - <b> Chembio Diagnostics, Inc. </b>(NASDAQ: <a href"http://www.marketwire.com/mw/stock.jsp?TickerCEMI">CEMI</a>) (OTCQB: <a href"http://www.marketwire.com/mw/stock.jsp?TickerCEMID">CEMID</a>) (PINKSHEETS: <a href"http://www.marketwire.com/mw/stock.jsp?TickerCEMI">CEMI</a>), which develops, manufactures, markets and licenses...Thu, 07 Jun 2012 12:00:00 AM GMThttp://www.qmed.com/news/allied-submits-ce-mark-application-cardiocelAllied Healthcare Group (ASX:AHZ) has submitted a CE Mark application for subsidiary Celxel's tissue matrix product, CardioCel, to help pave the way for its sale in Europe. The company has lodged the application with its European Notified Body. The submission will be evaluated by this body, as well as the UK's Medicines and Healthcare Regulatory Agency. A notified body is an organisation that has been...Wed, 06 Jun 2012 12:00:00 AM GMThttp://www.webmd.com/hiv-aids/news/20120515/first-at-home-hiv-test-nears-approvalBETHLEHEM, PA, May 15, 2012 -- OraSure Technologies, Inc. (NASDAQ: OSUR) today announced that the U.S. Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) provided a unanimous positive recommendation for the Companys OraQuick In-Home HIV Test. The BPAC provides advice to the FDA on issues related to the safety and effectiveness of biological products and medical devices seeking...Wed, 16 May 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=260094&full=1SUNNYVALE, Calif.--(BUSINESS WIRE)-- U-Systems, the leader in automated breast ultrasound, announced today it has received a PMA approvable letter from the U.S. Food and Drug Administrations (FDA) for the companys somov Automated Breast Ultrasound (ABUS) system. The somov ABUS system is the first ultrasound device to receive an approval recommendation from a FDA Advisory Panel and an approvable...Mon, 14 May 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=259477&full=1NORCROSS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc., (OTCBB: GTHP.OB - News) (OTCQB: GTHP.OB - News), today announced that it has submitted its formal response to the U.S. Food and Drug Administration (FDA) not-approvable letter for the LuVivaAdvanced Cervical Scan, which the Company received in January. The Companys response provided additional information as requested by the agency and also...Wed, 09 May 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=259230&full=1ALPHARETTA, Ga.--(BUSINESS WIRE)-- SANUWAVE Health, Inc. (OTCBB: SNWV.OB - News) today reported that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its Investigational Device Exemption (IDE) Supplement for an additional clinical trial utilizing the Companys dermaPACE device in the treatment of diabetic foot ulcers. The Company estimates the clinical trial could be...Tue, 08 May 2012 12:00:00 AM GMThttp://www.startribune.com/business/149224165.htmlCLEMENTE, Calif., April 26, 2012 /PRNewswire/ -- Cameron Health, Inc. ("Cameron Health"), a pioneer in the development, manufacture and distribution of next generation implantable cardioverter defibrillators (ICDs), announced today that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel voted 7-1 that sufficient data exists demonstrating the efficacy and safety of the S-ICD...Fri, 27 Apr 2012 12:00:00 AM GMThttp://www.cbsnews.com/8301-505245_162-57421810/ahead-of-the-bell-heartware-up-on-fda-panel-nod/FRAMINGHAM, Mass.</span> and <span class"xn-location">SYDNEY</span>, <span class"xn-chron">April 25, 2012</span> /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration's (FDA...Thu, 26 Apr 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20120424005357&newsLang=enKANSAS CITY, Mo.--(BUSINESS WIRE)--Diatron Group (Diatron), a Swiss-based company and global provider of hematology and clinical chemistry analyzers, has received FDA 510(k) premarket approval for its advanced laser optics hematology analyzer. The approval allows Diatron to begin commercial operations for the device in the U.S.Tue, 24 Apr 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=255754&full=1<div id"releaseBody"><p>IRVINE, CA--(Marketwire - April 09, 2012) - Edwards Lifesciences Corporation (NYSE: <a href"http://www.marketwire.com/mw/stock.jsp?TickerEW">EW</a>), the global leader in the science of heart valves and hemodynamic monitoring, today announced that a U.S. Food and Drug Administration (FDA) Advisory Panel has proposed a review of the company's Premarket Approval (PMA...Mon, 09 Apr 2012 12:00:00 AM GMThttp://www.massdevice.com/news/dune-medical-lands-fda-panel-date-marginprobe-breast-cancer-deviceThe FDA's general & plastic surgery devices advisory panel is slated to convene June 21 for a hearing on Dune Medical's MarginProbe breast cancer diagnosis tool. Dune Medical Devices has a date with the FDA to review its pre-market approval application for the MarginProbe breast cancer detection device. The watchdog agency's general & plastic surgery devices advisory panel scheduled a hearing for June...Fri, 06 Apr 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20120319005441&newsLang=enSAN CLEMENTE, Calif.--(BUSINESS WIRE)--Cameron Health, Inc. (Cameron Health) announced today that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel will review the Premarket Approval (PMA) application of the S-ICD System on April 26, 2012.Mon, 19 Mar 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=249636&full=1<div class"xn-content"><p /><p /><p><span class"xn-location">FRAMINGHAM, Mass.</span> and <span class"xn-location">SYDNEY</span>, <span class"xn-chron">Feb. 14, 2012</span> /PRNewswire/ -- HeartWare International, Inc. (NASDAQ: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, announced...Tue, 14 Feb 2012 12:00:00 AM GMThttp://www.rttnews.com/1817336/neurogesx-s-hiv-pain-patch-rejected-by-fda-panel-quick-facts.aspxA Food and Drug Administration panel of outside experts on Thursday ruled against using a pain-relief product derived from chili peppers to treat the pain that afflicts many HIV patients suffer in their extremities. In a 12-0 vote, the FDA advisory committee found that clinical data did not show substantial evidence that NeurogesX Inc's Qutenza capsaicin patch was effective at treating neuropathic...Fri, 10 Feb 2012 12:00:00 AM GMThttp://bostonglobe.com/business/2012/02/06/mindchild-files-fda-application-for-fetal-heart-monitor/nJUIlH5vNtZRl5aOPcPKXI/story.htmlNORTH ANDOVER, Mass.--(BUSINESS WIRE)--MindChild Medical, Inc. today announced that it has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its MERIDIAN non-invasive fetal heart monitor. MindChild expects feedback from the FDA during the next quarter and anticipates entering the US market with MERIDIAN following FDA...Mon, 06 Feb 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20120206005407&newsLang=enTEL AVIV, Israel--(BUSINESS WIRE)--ETView (TASE: ETVW) today announced that the company has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA). The Company expects feedback from the FDA during the next quarter and anticipates entering the US market with the Viva EB during 2012. Additional pre-market regulatory filings in...Mon, 06 Feb 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace2/index.jsp?ndmViewId=news_view&newsId=20120203005678&newsLang=enPLANO, Texas--(BUSINESS WIRE)--VuCOMP, Inc., developer of computer-aided detection (CAD) systems for automatic analysis of medical imagery, is pleased to announce premarket approval (PMA) of M-Vu, a cutting-edge CAD system for film mammography. M-Vu is indicated for use in screening mammography to identify areas consistent with breast cancer for radiologist review after completing an initial read...Fri, 03 Feb 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20120130006559&newsLang=enALT LAKE CITY--(BUSINESS WIRE)--Idaho Technology, Inc. announced today that it has filed a submission with the U.S. Food and Drug Administration for 510(k) clearance of five additional respiratory pathogens for its FilmArray Respiratory Panel, a user-friendly Multiplex PCR assay currently FDA cleared for 15 respiratory pathogens. The additional five pathogens are: Bordetella pertussis, Chlamydophila...Tue, 31 Jan 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=247196&full=1<div class"xn-content"><p>TIRAT CARMEL, <span class"xn-location">Israel</span>, <span class"xn-chron">January 24, 2012</span> /PRNewswire/ --</p><p>InSightec Ltd, the leader in MR guided Focused Ultrasound therapy, announced that it has submitted a premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for its <a href"http://www.bone-pain-palliation.co.uk/">ExAblate...Tue, 24 Jan 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20120120005940&newsLang=enNORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) today announced that the company plans to seek an independent panel review of its Pre-market Approval (PMA) application for the LuViva Advanced Cervical Scan from the U.S. Food and Drug Administration (FDA) after receiving a not-approvable letter from the agency. Meanwhile, the company plans to work with FDA to address...Mon, 23 Jan 2012 12:00:00 AM GMThttp://www.bizjournals.com/twincities/print-edition/2012/01/13/uromedicas-new-round-in-fight-for-fda.html?ana=otjrssMinneapolis / St. Paul Business Journal by Katharine Grayson, Staff reporter </p><p>Tim Cooks battle to get his firms medical technology approved for sale in the United States is once again in regulatory authorities court.</p><p>Cook is president and CEO of Uromedica Inc., a Plymouth-based firm that developed a pair of devices that treat urinary incontinence. The company is doing brisk business...Fri, 13 Jan 2012 12:00:00 AM GMTRALEIGH, N.C.--(BUSINESS WIRE)--LipoScience, Inc., an in vitro diagnostic company advancing patient care by developing high value proprietary clinical tests using nuclear magnetic resonance (NMR) technology, today announced that it has submitted the Vantera Clinical Analyzer and the NMR LipoProfile test to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. If cleared, Vantera would...Thu, 05 Jan 2012 12:00:00 AM GMT