BioSpace.com News

Quality First International Release: New ASEAN Draft Medical Device Directive: Will It Create the Hoped for Economic Boost for the Region?

Thu, 23 May 2013 12:00:00 AM GMT

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

London, 23 May 2013 -- Haroon Atchia CEO of the London-based medical device regulatory consultancy Quality First International has written a critical examination of the draft Association of Southeast Asian...

Direct Flow Medical, Inc. Receives IDE Approval for U.S. Salus Trial of Transcatheter Aortic Heart Valve System

Fri, 17 May 2013 12:00:00 AM GMT

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

SANTA ROSA, Calif., May 16, 2013 - Direct Flow Medical, Inc., a transcatheter heart valve company focused on improving patient outcomes, today announced that it has received approval from the United States...

Invacare Corporation Proving Itself to the FDA

Tue, 14 May 2013 12:00:00 AM GMT

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

Invacare Corporation Receives FDA Acceptance of First Certification Audit Related to Consent Decree

ELYRIA, Ohio--Invacare Corporation (NYSE: IVC) today announced that the United States Food...

Staff Shakeup Underway at Russian Medical Device Regulator, Emergo Group

Tue, 14 May 2013 12:00:00 AM GMT

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope...

BSD Medical Announces BSD-2000 Marketing Approval Submission to by Linden Bioscience

Mon, 13 May 2013 12:00:00 AM GMT

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

SALT LAKE CITY--(BUSINESS WIRE)--BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD) (www.BSDMedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, announced today...

SANUWAVE, Inc. Completes Investigator Meeting

Mon, 13 May 2013 12:00:00 AM GMT

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

ALPHARETTA, Ga., May 13, 2013 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCBB:SNWV) today announced that the Company held an investigator meeting in Atlanta, Georgia on May 10-11, 2013. The meeting served as...

GE Healthcare???s Entire New CT Portfolio Meets MITA???s Smart Dose Standard

Tue, 07 May 2013 12:00:00 AM GMT

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

MILWAUKEE--(BUSINESS WIRE)--GE Healthcare continues to be a leader in dose-reduction features with the announcement that all of its new CT products meet the Medical Imaging and Technology Alliance (MITA) smart...

The Internationally Known Medical Device Regulatory Expert, Has Published the First Fundamental and Critical Examination of the Proposal Regulation

Mon, 29 Apr 2013 12:00:00 AM GMT

London, 24 April 2013 - Haroon Atchia - CEO of the London-based medical device regulatory consultancy Quality First International - has written the first available in-depth examination of the proposal of a new medical device regulation in the European Union, as submitted by DG SANCO of the European Commission, Brussels.

The document offers an encompassing, one-stop access to the subject and...

InSpire MD Receives Approval From FDA to Begin US Regulatory Trial

Tue, 23 Apr 2013 12:00:00 AM GMT

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

BOSTON and TEL-AVIV, Israel, April 23, 2013 /PRNewswire/ --

InspireMD, Inc. (NYSE MKT: NSPR) ("Inspire" or the "Company"), the developer of the MGuard(TM) Embolic Protection Stent (EPS), announced...

Global Regulatory Affairs Specialist Receives Accreditation to Provide Readability Testing in Romania

Tue, 23 Apr 2013 12:00:00 AM GMT

Cambridge, UK, 23rd April, 2013 ELC GROUP, one of the fastest-growing providers of regulatory affairs consulting services, today announces that the National Agency for Medicines and Medical Devices (NAMMD) has issued ELC Group with accreditation to conduct Readability Testing in Romania. ELC Group is one of only three companies currently authorised to test patient information leaflet (PIL) readability...

Frog-Like Robot Will Help Surgeons, University of Leeds Study

Thu, 18 Apr 2013 12:00:00 AM GMT

Researchers at the University of Leeds are using the feet of tree frogs as a model for a tiny robot designed to crawl inside patients' bodies during keyhole surgery.

Insight Genetics Receives ISO 9001:2008 Certification

Wed, 17 Apr 2013 12:00:00 AM GMT

NASHVILLE, Tenn.--(BUSINESS WIRE)--Insight Genetics, a molecular diagnostics company focused on advancing precision medicine in cancer care, today announced that its Quality Management System has received ISO 9001:2008 certification. This milestone achievement, issued on March 12, 2013, represents an international consensus on good management practices and quality assurance.

US Regulatory Agency Provides Favorable Review and Recommends Path for Approval - TSO3 Inc. to Pursue De Novo Process Classification

Wed, 17 Apr 2013 12:00:00 AM GMT

QUEBEC CITY, QC, April 17, 2013 /CNW Telbec/ - TSO3 Inc. ("TSO3") an innovator in low-temperature sterilization technology for medical devices in healthcare settings, today announced that upon review of the current 510(k) submission for the STERIZONE 125L Sterilizer, the US Regulatory Agency has recognized the quality of the science provided and the performance of the device, as well as the uniqueness...

Rapid Micro Biosystems Announces ISO 9001:2008 Certification

Tue, 16 Apr 2013 12:00:00 AM GMT

BEDFORD, MA--(Marketwired - April 16, 2013) -

Highlighted Links

Growth Direct Workshops

Regulatory Affairs Professionals Society Webcast to Examine EU In Vitro Diagnostics (IVDs) Regulation

Mon, 25 Mar 2013 12:00:00 AM GMT

25 March 2013 -- The Regulatory Affairs Professionals Society (RAPS) will host a webcast, 27 March at 12:00 pm EDT, examining changes expected in the new EU in vitro diagnostics (IVDs) regulation.

Erik Vollebregt, partner with Amsterdam-based Axon Lawyers,will outline proposed changes and examine potential action items and how to implement them in regulated companies technical files and...

Meridian Bioscience, Inc. Announces illumigene® Group A Streptococcus and illumigene® Group B Streptococcus Tests Categorized "Moderate Complexity" by FDA

Mon, 18 Mar 2013 12:00:00 AM GMT

CINCINNATI--(BUSINESS WIRE)--Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) today announced the U.S. Food & Drug Administration (FDA) has re-categorized Meridians illumigene Group A Streptococcus and illumigene Group B Streptococcus tests as Moderate Complexity under the Clinical Laboratory Improvement Amendments (CLIA). Moderately complex tests are assays that are considered to be...

Troubles Continue for Intuitive Surgical, Inc. as Shares Keep Falling

Fri, 15 Mar 2013 12:00:00 AM GMT

Troubles continued for robotic surgeon maker Intuitive Surgical Inc., as shares took another tumble Thursday following the companys explanation of recent federal scrutiny over its da Vinci devices. Intuitive ISRG -0.39% shares fell by nearly 4% to $489.89, a day after the company said a rise in reports of troubles with its machines are due mostly to a revised reporting practice. The company said it...

WuXi PharmaTech Co., Ltd. Receives Letter From AAALAC Commending Animal Care at Suzhou Toxicology Facility as "Exemplary"

Thu, 14 Mar 2013 12:00:00 AM GMT

SHANGHAI, March 13, 2013 /PRNewswire/ -- WuXi PharmaTech (NYSE: WX), a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, announced today that its...

Regulatory Affairs Professionals Society, Singapore to Collaborate on First Medical Device Regulatory Training Program in Southeast Asia

Thu, 14 Mar 2013 12:00:00 AM GMT

SingaporeThe Regulatory Affairs Professionals Society (RAPS) is partnering with five Singapore government agencies to develop and implement a new medical device regulatory affairs (MDRA) training program by the end of 2013. In addition to covering the regulatory systems of the US, Europe and Asia Pacific markets, the training program will be the worlds first to offer instruction focused on the medical...

SFL Announces New Training Courses on EU Medical Devices and Combination Products Regulations

Mon, 11 Mar 2013 12:00:00 AM GMT

SFL is pleased to announce two upcoming training courses, each of which can be bookedseparately, that will provide a comprehensive overview of the EU Medical Devices andCombination Products regulations. These courses, which will be held in Basel, Switzerland, are ideal for both experienced professionals and newcomers in medtech, pharma or relatedlife science industries. They aim to improve...

Medtronic, Inc. Scores Regulatory Approval to Update CE Mark for Drug-Eluting Stent

Tue, 05 Mar 2013 12:00:00 AM GMT

MINNEAPOLIS March 4, 2013 Of relevance to the clinical practice of interventional cardiology, Medtronic, Inc. (NYSE: MDT) announced today that it has received regulatory approval to update the CE (Conformit Europenne) mark labeling for the Resolute Integrity drug-eluting stent with new information on one month of dual antiplatelet therapy (DAPT), the shortest minimum duration referenced on...

Availability of s The NGAL TestTM for ADVIA?? systems

Tue, 05 Mar 2013 12:00:00 AM GMT

BioPorto recently achieved the CE marked application note for Siemens ADVIA 2400 Chemistry System. Siemens Diagnostics has sent a follow-up communication to their international subsidiaries regarding the availability of The NGAL Test for Siemens ADVIA 1800 and ADVIA 2400 Chemistry Systems. The communication specifies that while BioPorto and Siemens Diagnostics continue to conduct business as...

Zyomyx, Inc. Receives ISO 13485: 2003 Certification

Thu, 28 Feb 2013 12:00:00 AM GMT

FREMONT, Calif., Feb. 28, 2013 /PRNewswire/ -- Zyomyx, Inc., developer of the first quantitative disposable CD4 diagnostic, has achieved ISO 13485: 2003 certification for its quality management system. Certification was awarded by BSI, one of the world's leading certification bodies.

Achieving ISO 134...

Regulatory Affairs Professionals Society Medical Device Submission and Compliance Workshop to Feature FDA Regulators, Industry Experts

Thu, 28 Feb 2013 12:00:00 AM GMT

Rockville, MD, USAThe Regulatory Affairs Professionals Society (RAPS) will host a two-day workshop on medical device submissions and compliance that will bring together experts from industry and officials from the US Food and Drug Administration (FDA) to address how device makers can work more effectively with FDA and meet evolving regulatory expectations. The workshop, Medical Device Submission ...

SpineGuard Wins Approval to Start Marketing PediGuard

Wed, 27 Feb 2013 12:00:00 AM GMT

SAN FRANCISCO & PARIS--(BUSINESS WIRE)--SpineGuard announced today that it has received regulatory approval from the Roszdravnadzor, the Russian healthcare agency that oversees medical devices, to market PediGuard in Russia.

SpineGuard further announced that it is partnering with Moscow-based Multi-Systems Technology ("MST") to sell PediGuard in Russia. MST has an extensive network of 5...

Avita Medical Completes ISO Quality Audit, CE Mark Recertification

Thu, 14 Feb 2013 12:00:00 AM GMT

NORTHRIDGE, CA and CAMBRIDGE, UNITED KINGDOM--(Marketwire - February 13, 2013) -

Highlighted Links

Avita Medical website

Avita Medical Ltd. (ASX: AVH) (OTCQX:

Guided Therapeutics, Inc. Passes Annual ISO Quality Audit Necessary for Continued CE Mark Certification

Thu, 14 Feb 2013 12:00:00 AM GMT

NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that it passed its annual independent quality audit and, with all external and mechanical testing completed, plans to apply the Edition 3 CE Mark to the LuViva Advanced Cervical Scan for expanded commercial introduction of the product in select European countries. Passing the annual ISO audit and...

New Book From Regulatory Affairs Professionals Society Examines Risk Management for Drugs and Medical Devices

Tue, 05 Feb 2013 12:00:00 AM GMT

Rockville, MD, USAThe Regulatory Affairs Professionals Society (RAPS) has published an authoritative new book covering the theory and application of risk management principles as they relate to the development and approval of drugs and medical devices.

The 145-page publication, Risk Management Principles for Devices and Pharmaceuticals: Global Perspectives on the Benefit: Risk Assessment...

Resonance Health Limited???s FerriScan® R2-MRI Receives FDA Marketing Authorization as the First Imaging Companion Diagnostic Device for Exjade® in Patients With Non-Transfusion-Dependent Thalassemia (NTDT)

Thu, 31 Jan 2013 12:00:00 AM GMT

SAN DIEGO--(BUSINESS WIRE)--The U.S. Food and Drug Administration recently announced the authorization of FerriScan R2-MRI1 to be marketed as an imaging companion diagnostic device for the safe and effective use of Exjade in patients with non-transfusion-dependent thalassemia2. Exjade (deferasirox) is a drug marketed by Novartis to remove excess iron in patients with genetic blood disorders.

Spectranetics Corporation Announces Expansion Into Japan Peripheral Intervention Market

Tue, 29 Jan 2013 12:00:00 AM GMT

COLORADO SPRINGS, Colo., Jan. 29, 2013 (GLOBE NEWSWIRE) -- The Spectranetics Corporation today announced regulatory and reimbursement approval by Japan's Ministry of Health, Labour and Welfare (MHLW) for its Quick-Cross Support Catheter for peripheral interventions. This approval enables a limited launch in targeted hospitals, followed by full launch later in 2013. Other products in the family, the...

Solos Endoscopy, Inc. and Schedule Stage 1 ISO 13485 Audit for February 26, 2013

Thu, 24 Jan 2013 12:00:00 AM GMT

BOSTON, Jan. 24, 2013 /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company and TUV SUD America has scheduled its Stage 1 ISO 13485 Audit for February 26, 2013.

Solos Endoscopy retained TUV SUD America, Inc. to complete its ISO 13485 Certification...

MiCardia Corporation Receives Notification of a New German Reimbursement Code for the Adjustment of Its enCorSQ Mitral Valve Repair System

Wed, 23 Jan 2013 12:00:00 AM GMT

IRVINE, Calif.--(BUSINESS WIRE)--MiCardia Corporation announced today it has received notification that a new German reimbursement code has been approved for the adjustment of the Companys enCorSQ Mitral Valve Repair SystemTM. This new code will provide additional reimbursement for the enCorSQ, a breakthrough approach to the long-term treatment of mitral valve disease. In particular, this new code...

National Institute for Clinical Excellence (NICE) Backs AF Blood Pressure Device

Fri, 18 Jan 2013 12:00:00 AM GMT

Detection and treatment of dangerous atrial fibrillation is vital. A new blood pressure measuring device that can also detect a dangerous heart condition has been backed by the health watchdog. New guidance from the National Institute for Clinical Excellence (NICE) supports the use of the 'WatchBP Home A' device by healthcare professionals in primary care to opportunistically detect atrial fibrillation...

Given Imaging Ltd. Announces New Reimbursement Code for Its SmartPill® Wireless Motility Capsule Procedure

Thu, 17 Jan 2013 12:00:00 AM GMT

YOQNEAM, ISRAEL--(Marketwire - January 17, 2013) - Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that effective January 1, 2013, the 2013 National Average Medicare Physician Fee allowable for its recently acquired SmartPill® Wireless...

Medical Implant Manufacturer Achieves AS9100C Aerospace Certification to Provide Products to the Aviation, Defense and Space Industries

Thu, 17 Jan 2013 12:00:00 AM GMT

NOBLESVILLE, Ind., Jan. 17, 2013 /PRNewswire/ -- RMI (www.rmi.us.com), a Noblesville, Indiana contract manufacturer of orthopedic implants and surgical instruments, has passed formal certification audits to provide components...

Connecticut Spring & Stamping Pursues ISO 13485 Medical Certification for Quality Management

Thu, 17 Jan 2013 12:00:00 AM GMT

Farmington, CT - Connecticut Spring & Stamping (CSS), a manufacturer of precision parts for the medical, aerospace, firearms and defense industries worldwide, announces that it is on schedule to be certified in 2013 to the ISO 13485 standard for quality management for design and manufacturing of medical devices.

CSS is currently certified to AS 9100, the standardized quality management system...

Advanced BioMedical Technologies Inc.'s Quality Management System Receives ISO 13485:2003 Certification

Tue, 15 Jan 2013 12:00:00 AM GMT

NEW YORK and SHENZHEN, China, Jan. 15, 2013 /PRNewswire/ -- Advanced BioMedical Technologies Inc. (OTCQB:ABMT), developer and manufacturer of orthopaedic internal fixation devices, is delighted to announce that the Company's Quality Management System (QMS) has been credited with ISO 13485:2003 certification...

NanoViricides, Inc. Retains for Design, Engineering and Construction of the Cleanroom Suite in its Previously Announced cGMP Production and Laboratory Facility

Mon, 14 Jan 2013 12:00:00 AM GMT

WEST HAVEN, Conn.--(BUSINESS WIRE)--NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has retained AES Clean Technology, Inc. (AES), for the design, engineering, and construction of the Cleanroom Suite for its laboratory and cGMP pilot production facility project. The Cleanroom Suite comprises the main cGMP manufacturing sections of the pilot plant. This Suite provides for...

Cook Medical Will "Not Give Up" Medical Device Tax Fight

Fri, 11 Jan 2013 12:00:00 AM GMT

The president of Bloomington-based Cook Medical says despite "considerable disappointment" that the fiscal cliff deal did not include a delay in a new medical device tax, the company will continue efforts to lobby lawmakers and the public. Kem Hawkins says the tax will cost Cook $20 million this year and slow down the development of new products.

St. Jude Medical Admits Quality-Control Issues, Promises Improvements

Wed, 09 Jan 2013 12:00:00 AM GMT

St. Jude Medical Inc. has told federal regulators that it will improve quality-control measures in making its Durata defibrillator leads, acknowledging criticism that has dogged the med-tech device maker for months. The Wall Street Journal reports that Little Canada-based St Jude, in a letter to the Food and Drug Administration, said it would increase training make other improvements at its Sylmar...

Laboratory Corporation of America Holdings (LabCorp) Biorepository Receives Industry Accreditation From College of American Pathologists

Wed, 09 Jan 2013 12:00:00 AM GMT

BURLINGTON, N.C.--(BUSINESS WIRE)--Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) today announced the recent accreditation of its Biorepository by the College of American Pathologists (CAP). CAPs inaugural accreditation program was developed to establish internationally-recognized best practices and quality standards for the collection, storage and future analysis of biospecimens...

Guided Therapeutics, Inc. Successfully Completes Canadian Standard Association Requirements for LuViva® Advanced Cervical Scan

Mon, 07 Jan 2013 12:00:00 AM GMT

NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc., (OTCBB: GTHP) (OTCQB: GTHP), today announced that it has successfully completed third-party testing of the LuViva Advanced Cervical Scan. This puts LuViva in compliance with Canadian Standards Association (CSA) requirements which, while not required for marketing in Canada, are preferred by certain larger medical institutions. It also puts...

Sensimed AG Receives a New Reimbursement Code in the USA by the American Medical Association for Intraocular Pressure Monitoring

Thu, 03 Jan 2013 12:00:00 AM GMT

LAUSANNE, SWITZERLAND--(Marketwire - January 03, 2013) - Sensimed AG, the developer of a revolutionary contact lens (the SENSIMED Triggerfish®) for the continuous monitoring of fluctuations in intraocular pressure (IOP) to facilitate the management of glaucoma, announced today that the American Medical Association (AMA) has approved a new Current Procedural Terminology...

AITbiotech Secured CE-IVD Certification for Its Influenza (Flu) and Mycobacteria Tuberculosis (MTB) Molecular Diagnostic Assays

Wed, 02 Jan 2013 12:00:00 AM GMT

Jan 2013 AITbiotech, a leading molecular Diagnostic (MDx) and Genomic Services provider in Singapore announced today, that it has secured CE-IVD Mark Certification for its abTES Flu 4-Plex and abTES MTB real-time PCR assays.

The CE clearance of abTES Flu and MTB qPCR Kits marked a significant milestone for AITbiotech in the year of 2012 after obtaining the ISO 13485:...

FDA Details Changes to Medical Device Review Groups

Thu, 20 Dec 2012 12:00:00 AM GMT

The FDA provides details on the breakdown for the new Office of In Vitro Diagnostics and Radiological Health, formerly known as the Office of In Vitro Diagnostic Device Evaluation and Safety.The FDA this week provided updates on the revamped Office of In Vitro Diagnostics & Radiological Health, formerly known as the Office of In Vitro Diagnostic Device Evaluation and Safety.

Exponent Inc. Release: Failure Analysis, Product Recalls, and Liability: Preventative Measures to Help Prevent the FDA From Knocking on Your Door

Thu, 20 Dec 2012 12:00:00 AM GMT

Click Here to Register for the Seminar

December 20, 2012 -- The current regulatory and litigation environments in the United States require that potential safety issues and problems with mass-produced products be vigorously investigated and quickly remedied.

How well a company manages a recall situation...

CardiacAssist, Inc. Receives FFA Sciences IDE Approval for Use of the TandemHeart System in Pivotal Clinical Study

Tue, 18 Dec 2012 12:00:00 AM GMT

PITTSBURGH--(BUSINESS WIRE)--CardiacAssist, Inc., a privately-held medical technology company headquartered in Pittsburgh, Pennsylvania, announced today that it received Investigational Device Exemption (IDE) approval from the Food & Drug Administration (FDA) for a pivotal clinical study of the TandemHeart circulatory support system. The TandemHeart to Reduce Infarct Size (TRIS) Trial will evaluate...

BioLargo, Inc. Achieves Breakout Milestones in Advanced Wound Care on Track for FDA 510(k) Submission and Commercialization

Mon, 17 Dec 2012 12:00:00 AM GMT

LA MIRADA, CA--(Marketwire - December 17, 2012) - BioLargo, Inc. (OTCBB: BLGO) announced today that it had accomplished a number of significant achievements in its march toward commercialization of advanced wound care products featuring its patented BioLargo technology.

First, preliminary formulations...

InVivo Therapeutics Corporation Requests Humanitarian Use Device Designation With FDA

Fri, 14 Dec 2012 12:00:00 AM GMT

CAMBRIDGE, Mass.---InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced that the Company has filed a request with the U.S. Food and Drug Administration (FDA) for Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product. InVivo is currently working...

Flexpoint Sensor Systems Inc. Completes Certification for Pressure Relief Device

Fri, 14 Dec 2012 12:00:00 AM GMT

DRAPER, Utah, Dec. 13, 2012 /PRNewswire/ -- Flexpoint Sensor Systems, Inc. (OTCBB: FLXT) today announced that it has completed development, passed all testing and received all required internal and external certifications, including UL certification, for...

Cohera Medical, Inc. Receives IDE Approval to Begin First No-Drain Clinical Study of TissuGlu® Surgical Adhesive in the U.S.

Thu, 13 Dec 2012 12:00:00 AM GMT

PITTSBURGH, Dec. 13, 2012 /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") to begin the first no-drain clinical trial for...

Maquet Cardiovascular LLC Announces FDA Panel Votes to Reclassify Intra-Aortic Balloon Pumps to a Class II Designation in Certain Indications

Thu, 13 Dec 2012 12:00:00 AM GMT

WAYNE, N.J., Dec. 13, 2012 /PRNewswire/ -- MAQUET Cardiovascular, the leader in intra-aortic balloon (IAB) therapy, today announced that the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) recently voted to support the Agency's reclassification of intra...

Abiomed Release: FDA 515i Reclassification Panel Recommends Class III Status for Temporary Ventricular Support Devices in the Non-Roller Type Cardiopulmonary Bypass Blood Pumps Category

Fri, 07 Dec 2012 12:00:00 AM GMT

DANVERS, Mass., Dec. 6, 2012 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced that the U.S. Food and Drug Administration's (FDA) Circulatory System Devices Panel voted to retain Class III status for the temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes...

Marcus Evans, Life Science and Pharma Conferences: Establish Strategies for Device Recalls and Corrections

Wed, 05 Dec 2012 12:00:00 AM GMT

Medical device safety is drawing intense scrutiny from global regulatory bodies, the press, professional literature and consumer groups. Task forces and working groups are examining potential changes to submissions and reporting requirements to ensure device safety, clinical trials are being required for 510(k) applications and many provisions are under consideration to foster FDA's efforts to ensure...

Vasomedical Inc.'s EECP® Therapy Receives Class IIb Rating in the New ACCF/AHA 2012 Clinical Guideline for SIHD

Tue, 27 Nov 2012 12:00:00 AM GMT

WESTBURY, N.Y., Nov. 27, 2012 /PRNewswire/ -- On November 19, The American College of Cardiology Foundation and American Heart Association (ACCF/AHA) Task Force on Practice...

Conceptus, Inc. Praises France's Decision to Remove Age Restrictions on Reimbursement for Essure® Permanent Birth Control

Wed, 14 Nov 2012 12:00:00 AM GMT

MOUNTAIN VIEW, Calif., Nov. 14, 2012 (GLOBE NEWSWIRE) -- Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure procedure, the leading surgery-free permanent birth control method, today praised the decision by France's UNCAM (Union nationale des caisses d'assurance maladie) to remove reimbursement restrictions on the placement of the intra-tubal insert Essure for all women seeking permanent contraception...

Nelson Laboratories Compliant With New FDA Medical Device Registration Requirement

Wed, 14 Nov 2012 12:00:00 AM GMT

SALT LAKE CITY, Nov. 14, 2012 /PRNewswire/ --Nelson Laboratories (www.nelsonlabs.com) today announced compliance with the FDA Safety and...

Final FDA Artificial Pancreas Guidance a Milestone for People With Type 1 Diabetes

Wed, 14 Nov 2012 12:00:00 AM GMT

--The FDA's final artificial pancreas guidance adopts JDRF's recommendations, providing a clear path toward improving lives by moving the transformative technology into the hands of millions with type 1 diabetes --

NEW YORK, Nov. 13, 2012 /PRNewswire-USNewswire/ --JDRF today called the...

Oxford Immunotec Limited RT-SPOT.TB Receives Regulatory Approval and Reimbursement Coding in Japan

Tue, 13 Nov 2012 12:00:00 AM GMT

Oxford, UK and Kawasaki, Japan; November 13, 2012 Oxford Immunotec, a medical diagnostic company developing tests in the fields of infectious and immunological disease, today announced that the T-SPOT.TB test has received regulatory approval from the Japanese Ministry of Health, Labour and Welfare (MHLW). The T-SPOT.TB test is a laboratory based cellular blood test that is intended for use...

Corgenix Medical Corporation Receives Regulatory Approval for Sale of AspirinWorks® in China

Mon, 12 Nov 2012 12:00:00 AM GMT

DENVER--(BUSINESS WIRE)--Corgenix Medical Corporation (OTC BB: CONX.OB), a worldwide developer and marketer of diagnostic test kits, announced today that the Companys AspirinWorks ELISA product has received notification of regulatory approval from the State Food and Drug Administration (SFDA) of the Peoples Republic of China. The approval enables Corgenix to begin commercialization of the AspirinWorks...

CellAegis Devices Inc. Announces Initiation of Clinical Testing of Remote Ischemic Conditioning (RIC) Using the autoRIC™ Device for Patients Undergoing Partial Nephrectomy

Mon, 12 Nov 2012 12:00:00 AM GMT

TORONTO--(BUSINESS WIRE)--CellAegis Devices, Inc., announced today that it has received an Investigational Testing Approval (ITA) from Health Canada which allows the initiation of clinical testing in Canada of the Companys autoRIC Device for remote ischemic conditioning (RIC). In a pilot clinical trial sponsored by Michael Jewett, M.D., of the University Health Network - Princess Margaret Hospital...

STD Med, Inc. Receives ANVISA Registration for Class III Medical Devices in Brazil

Fri, 09 Nov 2012 12:00:00 AM GMT

STOUGHTON, Mass., Nov. 8, 2012 /PRNewswire/ -- STD Med, Inc. is pleased to announce that it has received a Certificate of Good Practices for Manufacturing of Class III Medical Devices from ANVISA, the Brazilian National Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria ANVISA). All medical devices...

NanoSight Limited Joins the EU Methods List Relating to "Nanomaterials"

Wed, 07 Nov 2012 12:00:00 AM GMT

Salisbury, UK, 7th November 2012: NanoSight, providers of unique nanoparticle tracking analysis technology (NTA) welcomes the publication of the European Commission report listing methods currently available for measurement of Nanomaterials, as defined by the EU in 2011.

This report, from the Joint Research Centre of the EU, defining the measurement of nanomaterials is entitled: Requirements...

Nanosphere, Inc.'s Bloodstream Infection Test Designated Moderate Complexity by FDA

Fri, 02 Nov 2012 12:00:00 AM GMT

NORTHBROOK, Ill., Nov. 1, 2012 (GLOBE NEWSWIRE) -- Nanosphere, Inc. (Nasdaq:NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, announced today that it received notice from the U.S. Food and Drug Administration (FDA) that its Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the Verigene System has been categorized as Clinical Laboratory Improvement...

GI Dynamics Receives FDA Approval to Commence Pivotal Clinical Trial of EndoBarrier®

Tue, 30 Oct 2012 12:00:00 AM GMT

GI Dynamics, Inc. (Company or GI Dynamics) (GID.AX) announced today that it has received full approval from the U.S. Food and Drug Administration (FDA) to commence a 25-site pivotal clinical trial of EndoBarrier for the treatment of patients who have uncontrolled type 2 diabetes and are obese. Data garnered from the U.S. clinical study, named the ENDO Trial, will be used to support a Premarket Application...

Exagen Diagnostics, Inc. Receives Avise SLE Certification In New York

Fri, 26 Oct 2012 12:00:00 AM GMT

ALBUQUERQUE, N.M., Oct. 25, 2012 /PRNewswire/ -- Exagen Diagnostics, Inc., a specialty focused molecular diagnostics laboratory that discovers, develops and markets proprietary tests for rheumatologists, announced today that it has received approval to offer...

Philips Respironics Simplygo Portable Oxygen Concentrator Receives FAA-Approval; Oxygen Patients Can Fly With Simplygo

Thu, 25 Oct 2012 12:00:00 AM GMT

MURRYSVILLE, Pa., Oct. 24, 2012 /PRNewswire/ -- Philips Respironics, a unit ofRoyal Philips Electronics (NYSE: PHG, AEX: PHI), announces that the United States Federal Aviation Administration (FAA) has approved the SimplyGo portable oxygen concentrator (POC) for in-flight use on commercial airliners...

Exagen Diagnostics, Inc. Receives Avise SLE Certification in New York

Thu, 25 Oct 2012 12:00:00 AM GMT

Merit Medical Systems, Inc. Announces FDA Completes Evaluation

Wed, 24 Oct 2012 12:00:00 AM GMT

SOUTH JORDAN, Utah, Oct. 23, 2012 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, today announced that the U.S. Food and Drug Administration (FDA) has completed its evaluation of Merit's corrective actions...

Sequenta Earns CLIA Certification

Wed, 24 Oct 2012 12:00:00 AM GMT

SAN FRANCISCO--(BUSINESS WIRE)--Sequenta, Inc. today announced it has received Clinical Laboratory Improvement Amendments (CLIA) certification for a clinical test based on the LymphoSIGHT platform, marking a critical milestone for the clinical use of this next generation sequencing method for the monitoring of blood cancers. Sequenta expects to launch its first commercial test in 2013.

EU Follows US Nod for Eli Lilly and Company's Brain Plaque Test

Fri, 19 Oct 2012 12:00:00 AM GMT

INDIANAPOLIS, Oct. 19, 2012 /PRNewswire/ --Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, today announced they received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe, recommending...

Quest Diagnostics Inc. Announces First EHRs Certified Under Laboratory-based Health IT Quality Solutions™ Program

Fri, 19 Oct 2012 12:00:00 AM GMT

MADISON, N.J., Oct.19, 2012 /PRNewswire/ --Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced the first electronic health record (EHR) solutions to be certified under its Health IT Quality Solutions Program. The program is designed to recognizeEHR solutions for achieving...

St. Jude Medical Sees Possible FDA Warning Letter; Shares Tumble

Wed, 17 Oct 2012 12:00:00 AM GMT

St. Jude Medical Inc (STJ.N) warned Wall Street that U.S. health regulators might issue a warning letter about one of its manufacturing facilities in California as it reported another weak quarterly performance. St. Jude shares fell 5.7 percent to $40.48 in early trading on the New York Stock Exchange. During a conference call with analysts, Chief Executive Officer Dan Starks said there was a possibility...

Fluxion Biosciences Registers South San Francisco Facility as Medical Device Establishment With FDA

Mon, 15 Oct 2012 12:00:00 AM GMT

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Fluxion Biosciences, Inc. announced today that it has registered its South San Francisco facility as a medical device establishment with the U.S. Food and Drug Administration. The company plans to use this facility to manufacture and distribute its IsoFlux System for circulating tumor cell analysis, which will be launched in November.

Solos Endoscopy, Inc. Reports Significant Progress on ISO 13485 Certification and Audit

Thu, 11 Oct 2012 12:00:00 AM GMT

BOSTON, Oct. 11, 2012 /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company has made significant progress in its efforts to complete its ISO 13485 Certification and Audit.

In his most recent "President's Letter", Solos Endoscopy President, Robert...

International Isotopes Announces Receipt of the Nuclear Regulatory Commission License for the Planned Depleted Uranium De-Conversion and Fluorine Extraction Processing Facility

Thu, 04 Oct 2012 12:00:00 AM GMT

IDAHO FALLS, Idaho, Oct. 3, 2012 /PRNewswire/ -- International Isotopes Inc. (OTC Bulletin Board: INIS) is pleased to announce that the United States Nuclear Regulatory Commission (NRC) has issued a Part 40 combined construction and operating license for the Company's planned depleted uranium de-conversion and...

Marcus Evans, Medical Device Summits Release: Monitoring the Safety of Post-Market Medical Devices

Wed, 03 Oct 2012 12:00:00 AM GMT

October 01, 2012 -- Given that the malfunction of a device can lead to fatality, the need to ensure these devices are safe and are monitored effectively is crucial. Any complaints on devices need to be monitored so that if there is a need to recall the device, it can be done effectively and quickly without any further impact to patients. One of the biggest challenges for many medical device manufacturers...

Roche Diagnostics Corporation Release: FDA Grants CLIA-Waived Status to CoaguChek XS Plus System for PT/INR Testing at the Point of Care

Mon, 01 Oct 2012 12:00:00 AM GMT

INDIANAPOLIS, Oct. 1, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted CLIA-waived status to the CoaguChek XS Plus system, a point-of-care anticoagulation monitor that offers connectivity and data management tools to help healthcare...

Mauna Kea Technologies Announces Important Regulatory Clearances in Turkey

Mon, 01 Oct 2012 12:00:00 AM GMT

PARIS--(Marketwire - October 01, 2012) - Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the endomicroscopy market and developer of Cellvizio® imaging, the fastest way to see cancer, announced that it has received clearance from the Turkish Ministry of Health to sell both its Cellvizio® 100 Series endomicroscopic imaging system and the new AQ Flex...

Genetic Technologies Limited Announces BREVAGen??? Attains Clearance for Sale Into Florida

Tue, 25 Sep 2012 12:00:00 AM GMT

MELBOURNE, AUSTRALIA--(Marketwire - September 25, 2012) - Genetic Technologies Limited (ASX: GTG) (NASDAQ: GENE) is pleased to announce that BREVAGen™ has been cleared for sale into the State of Florida following the grant of a permit to the Company's Australian-based laboratory by the Clinical Laboratory...