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Designing Medical Devices to Meet FDA Security Guidelines

December 13, 2013 3:18 pm | by Alan Grau, President and Co-Founder, Icon Labs | Articles | Comments

The FDA and Department of Homeland Security recently issued an alert urging medical device makers and medical facilities to upgrade security protections to protect against potential cyber threats. This was issued in response to an ICS-CERT...

AdvaMed Applauds FDA User Fee Sequester Relief, Device Tax Repeal Language in Budget Deal

December 13, 2013 12:44 pm | by AdvaMed | News | Comments

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement today on the bipartisan federal budget agreement for fiscal years 2014 and 2015. “AdvaMed commends Chairmen Patty...

Nipple Aspirate Test Is No Substitute for Mammogram

December 13, 2013 11:33 am | by FDA | News | Comments

Many women admit that getting a mammogram is no fun, and may wish there was an easier, more comfortable way to screen for breast cancer in its earliest and most treatable stages. Some companies today are promoting a test in which a breast...

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Photo of the Day: Clarifying Breast Cancer Diagnosis

December 13, 2013 11:32 am | by FDA | News | Comments

FDA is unaware of any valid scientific data to show that nipple aspirate tests, when used on their own, are an effective screening tool for any medical condition, including the detection of breast cancer or other breast disease. Researchers...

FDA launches medtech 'voluntary compliance' pilot

December 13, 2013 7:29 am | by Mass Device | News | Comments

Federal healthcare regulators are inviting certain medical device companies to self-report regulatory violations, promising that companies that cooperate will get to avoid FDA inspections. Participants must retain an outside consultant to assess...

Case for Quality

December 11, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Through the Case for Quality, the FDA is working with stakeholders?industry, healthcare providers, patients, payers, and investors ? to foster medical device quality. Enhancing the quality of medical devices is in the best interests of all...

mHealth: Mega Electronics lands FDA win for smartphone ECG monitor

December 6, 2013 2:39 pm | by Mass Device | News | Comments

Finnish medical device maker Mega Electronics won FDA approval for its eMotion continuous ECG monitor, designed to work with Android-based smartphones. The system provides real-time remote heart rhythm monitoring that collects data and... 

FDA Reaches $1.25M Settlement with J&J Unit

December 6, 2013 9:33 am | by The Associated Press | News | Comments

The Food and Drug Administration said Wednesday that it reached a $1.25 million settlement with a division of Johnson & Johnson over allegations that it knowingly shipped faulty sterilization equipment used by hospitals. Under the civil...

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PMDA Approves Jarvik 2000 Heart in Japan

December 5, 2013 1:45 pm | by PR Newswire | News | Comments

JARVIK HEART, Inc., a privately-held company that develops and manufactures cardiac assist devices, announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval to the Shonin (or pre-market approval)...

The Pulse: Medical 'Ro-Butt' & Reinventing Healthcare

December 5, 2013 9:07 am | by Eric Sorensen, Coordinator of Multimedia Development | Videos | Comments

This week on The Pulse, we are giving virtual prostate exams, teaching kids with autism, launching a new style of mobility device, and reinventing healthcare with L.A. billionaire Dr. Patrick Soon-Shiong. This episode features:   

As Da Vinci Robot Lawsuits Mount, Bernstein Liebhard LLP Comments on Latest Da Vinci Robot Instrument Recall

December 4, 2013 4:49 pm | by PR Newswire | News | Comments

As da Vinci robot lawsuits continue to mount against Intuitive Surgical, Inc., Bernstein Liebhard LLP notes that the U.S. Food & Drug Administration (FDA)  has announced a Class II recall for some instruments used with the da Vinci Surgical...

Using ISO 21500 as the PMO Backbone for Medical Device Development

December 4, 2013 1:44 pm | by Martine Janicki Ph.D., PEng, PMP, Medical Device Engineer and Project Management Officer, StarFish Medical | Blogs | Comments

It’s been a year since the International Standard Organization released its ISO 21500 –Guidance on Project Management. That’s about the same time StarFish Medical started its Project Management Office (PMO). This blog will explain the differences...

The S3 Challenge Conference

December 4, 2013 12:59 pm | Events

AAMI and the U.S. Food and Drug Administration (FDA) today announced plans for S3 Challenge 2014—a dynamic new conference set for March that will focus on how to improve the safety of healthcare technology and reduce the time it takes to...

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Proposed New ASTM Standard to Provide Guide for Collection and Analysis of Explanted Hip Implants

December 4, 2013 12:12 pm | by ASTM | News | Comments

An ASTM International symposium on metal-on-metal total hip replacement devices held in May 2012 identified unmet standardization needs. One such need was for a standard that deals with the collection and analysis of explanted hip implants...

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...

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...

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...

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