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Survey: Regulatory Agencies Viewed as Unprepared for Nanotechnology

December 19, 2013 11:06 am | by University of California - Santa Barbara | News | Comments

Three stakeholder groups agree that regulators are not adequately prepared to manage the risks posed by nanotechnology, according to a paper published in the peer-reviewed journal PLOS One. In a survey of nano-scientists and engineers...  

USDM Life Sciences Hires FDA's Unique Device Identification Architect, Jay Crowley as Vice President of UDI Practice

December 19, 2013 10:39 am | by The Associated Press | News | Comments

USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, hires Jay Crowley as Vice President of the Unique Device Identification (UDI) practice. As Senior Advisor for Patient Safety in the Food and Drug...

FDA: Intuitive Surgical recalls are Class II

December 18, 2013 4:38 pm | by Mass Device | News | Comments

A pair of recalls affecting more than 110,000 components of Intuitive Surgical's flagship da Vinci surgical robot pose only a slight risk of serious consequences, the FDA said this week. Intuitive notified customers Nov. 15 of the potential...


GS1 Named an Accredited Issuing Agency for UDI by FDA

December 17, 2013 12:40 pm | by GS1 | News | Comments

GS1, a leading global standards organization, was accredited today by the U.S. Food and Drug Administration (FDA) as an issuing agency for unique device identifiers (UDIs). Global GS1 Standards, administered in the U.S. by GS1 US, were recognized...

CE Mark and First Implants of Boston Scientific’s X4 Quadripolar CRT-D Systems

December 17, 2013 10:02 am | by PR Newswire | News | Comments

Boston Scientific Corporation has received CE Mark approval of its X4 line of quadripolar CRT-D systems, including the AUTOGEN X4, DYNAGEN X4, and INOGEN X4 cardiac resynchronization therapy defibrillators (CRT-Ds), a suite of ACUITY X4... 

FDA OKs eNeura's novel migraine pain treatment stim

December 17, 2013 9:29 am | by Mass Device | News | Comments

Medtech maker eNeura Therapeutics won FDA clearance to market its 1st-of-its-kind Cerena transcranial magnetic stimulator, landing regulatory approval through the agency's less-stringent de novo premarket review pathway. The Cerena TMS is...

Overview of Medical Device Classification and Reclassification

December 17, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On July 9, 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA). Section 608(c) of FDASIA requires the FDA to annually post the number and type of medical devices reclassified in the previous calendar...

Medical Device Reclassification

December 17, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

As experience and knowledge about a device increase, the original classification of a device can be changed through reclassification. Two reclassification processes for medical devices described in the Food Drug and Cosmetic Act are explained...


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...

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...

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...

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...

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