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Exact Sciences Announces Date for FDA Advisory Committee Meeting

December 3, 2013 4:15 pm | by Business Wire | News | Comments

Exact Sciences Corp. today announced that the U.S. Food and Drug Administration’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the premarket approval application for the...

Abbott Issues Voluntary Recall of Blood Glucose Test Strips

December 3, 2013 11:31 am | by FDA | News | Comments

Abbott has announced it is initiating a voluntary recall of 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips in the United States. These lots of test strips may produce erroneously low blood glucose results when used with both...

Voluntary Recall of Philips Automated External Defibrillators

December 3, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

In September 2012, Philips Healthcare initiated a Voluntary Medical Device Recall of HeartStart Frx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs after determining that an internal electrical component in the AED could fail, and the...

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PMA Final Decisions for August 2013

December 3, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for August 2013. Approval for the Mobi-C Cervical Disc Prosthesis. This device is indicated in skeletally mature patients for reconstruction...

Diabetes: Abbott recalls blood glucose test strips

December 2, 2013 1:58 pm | by Mass Device | News | Comments

Abbott Diabetes Care said it issued a recall of its FreeStyle blood glucose test strips after reports of falsely low results. The Alameda, Calif.-based medical device company found that the FreeStyle test strips used with Insulet's OmniPod...

Another Class I recall for Hospira's GemStar infusion system

November 26, 2013 11:51 am | by Mass Device | News | Comments

FDA regulators issued their highest-risk Class I status on a recall of Hospira's GemStar portable infusion systems, warning that issues with the devices' pressure sensors may result in significant patient harm or death. The affected GemStar...

MITA Announces Support of Medical Device Single Audit Program

November 26, 2013 10:31 am | by MITA | News | Comments

The Medical Imaging & Technology Alliance (MITA) today announced its support of the pilot program for the Medical Device Single Audit Program (MDSAP), the details of which were unveiled this week at the November 2013 IMDRF Stakeholder...

FDA Warns Genetic Test Maker 23andMe

November 25, 2013 3:26 pm | by The Associated Press | News | Comments

Federal health regulators have ordered genetic testing company 23andMe to stop selling its main product because it has not been proven safe and effective. In a harshly worded warning letter, the FDA says the Silicon Valley company has not...

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Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only - Guidance for Industry and Food and Drug Administration Staff

November 22, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

FDA is issuing this guidance document to provide the current thinking of the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) on when in vitro diagnostic (IVD) products are properly...

Gene Sequencing Devices Are ‘Next Generation’

November 21, 2013 3:10 pm | by Jeffrey Shuren, M.D., Director, CDRH | Blogs | Comments

Just for a moment, imagine a scenario in which you have an illness that has eluded diagnosis. The usual suspects have been ruled out and no one knows exactly what’s making you sick. Using medical devices that FDA has now cleared for marketing...

'Software is not a medical device': FDA medtech chief battles for control of mHealth

November 21, 2013 1:56 pm | by Mass Device | News | Comments

The conversation got a bit heated this week as the House Energy & Commerce Committee's subcommittee on Health sparred with FDA medical device chief Jeffrey Shuren over regulation of mobile medical and healthcare applications. Shuren...

AdvaMed Statement on House FDASIA Hearing

November 19, 2013 12:07 pm | by AdvaMed | News | Comments

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association, released the following statement on today’s hearing in the House Energy and Commerce Health Subcommittee on implementation of the FDA Safety and Innovation...

FDA Issues Stern Warning on Medtronic Devices

November 16, 2013 7:19 pm | by David Koenig - AP Business Writer | News | Comments

Federal health officials say that defects in some Medtronic devices used in heart procedures are severe enough that they could cause serious injury or death. The warning covers about 15,000 recalled guidewires, which are inserted through an artery...

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New Factors Reshaping Medical Education Programs in the Life Sciences Industries

November 15, 2013 3:50 pm | by PR Newswire | News | Comments

Medical Education groups are often being transformed by regulatory and budget pressures, making it increasingly difficult to effectively educate healthcare practitioners on the safe and effective use of products. With the pressure to reduce budgets...

Consumer Information on: MitraClip Clip Delivery System

November 15, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

  This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications...  

7 Tips for Painless FDA 510(k) Regulatory Submissions

November 13, 2013 3:30 pm | by Vincent Crabtree, Ph.D., Regulatory Advisor and Project Manager, StarFish Medical | Blogs | Comments

FDA Regulatory Clearance using the 510(k) Pre-market Notification process can be a painful experience to unprepared companies. My focus at StarFish Medical is regulatory compliance. I believe it is important to consider Regulatory all the way...

USDM Life Sciences Teams With Inspirage to Help Medical Device Manufacturers Meet FDA's Unique Device Identifier (UDI) Compliance Regulations

November 13, 2013 12:24 pm | by The Associated Press | News | Comments

USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, is proud to announce a teaming agreement with Inspirage to provide comprehensive consulting and technology solutions for medical device companies to...

Meeting Notice: December 11, 2013 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

November 12, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On December 11, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application regarding the Boston Scientific WATCHMAN Left Atrial Appendage (LAA) Closure Technology. The WATCHMAN...

Health Website's Security Prompts Worries

November 6, 2013 4:05 pm | by Ricardo Alonso-Zaldivar, Associated Press | News | Comments

Obama administration officials are facing mounting questions about whether they cut corners on security testing while rushing to meet a self-imposed deadline to launch online health insurance markets. Documents show that the part of HealthCare.gov that consumers interact with ...

Photos of the Day: Venezuela's Crippled Healthcare

November 6, 2013 12:07 pm | by The Associated Press | News | Comments

Venezuela's 1999 constitution guarantees free universal health care to Venezuelans, who sit on the world's largest proven oil reserves. President Nicolas Maduro's government insists it's complying. Yet of the country's 100 fully functioning public hospitals ...

Doctors Say Venezuela's Health Care in Collapse

November 6, 2013 11:59 am | by Frank Bajak, Associated Press | News | Comments

Evelina Gonzalez was supposed to undergo cancer surgery in July following chemotherapy but wound up shuttling from hospital to hospital in search of an available operating table. On the crest of her left breast, a ...     

Samsung Aims to Be Top Medical Device Maker

November 6, 2013 10:38 am | by Youkyung Lee, AP Technology Writer | News | Comments

Samsung wants to be the top medical device maker through acquiring companies and developing its own technologies. In the last three years, Samsung spent $1 billion to buy 14 companies in medical equipment, mobile software and services ...

Testosterone Treatments Linked to Heart Risks

November 6, 2013 10:18 am | by Lindsey Tanner, AP Medical Writer | News | Comments

Testosterone treatments may increase risks for heart attacks, strokes and death in older men with low hormone levels and other health problems, a big Veterans Affairs study suggests. The results raise concerns about ...     

RFID Chips for Breast Implants

November 1, 2013 10:45 am | by Business Wire | News | Comments

VeriTeQ Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, has announced that it has delivered its first order of 2,000 Q Inside Safety Technology radio frequency identification...

U.S. FDA shares more details on MDSAP international audit pilot

October 28, 2013 3:47 pm | by Mass Device | News | Comments

Following the Australian Therapeutic Goods Administration’s recent news that Australia, Brazil, Canada and the US will launch a pilot for the Medical Device Single Audit Program (MDSAP) for medical devices in January 2014, The US Food and Drug... 

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