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Medtronic Announces First Implants in Largest-Ever, Global Trial of Cardiac Resynchronization Therapy

August 27, 2014 12:10 pm | by The Associated Press | News | Comments

Medtronic, Inc. has announced the first implants in a clinical trial that will compare patient and healthcare system outcomes - including patient mortality and hospitalizations - in heart failure patients who have cardiac resynchronization...

St. Jude Medical Resolves FDA Warning Letter for Plano Facility

August 27, 2014 9:22 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, has announced that it has been notified by the U.S. Food and Drug Administration (FDA) that issues cited in the Plano, Texas, facility’s warning letter have been addressed. “We’re...

TIA Commends New FDA Approach to Medical Device Data Systems

August 26, 2014 12:01 pm | by Telecommunications Industry Association | News | Comments

The Telecommunications Industry Association (TIA), the leading association representing the manufacturers and suppliers of high-tech communications networks, today submitted comments to the Food and Drug Administration (FDA) in support...

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Risky Device MMAs Should Be Regulated

August 25, 2014 2:31 pm | by Steven G. Richter, Ph.D., President and Chief Scientific Officer, Microtest Laboratories Inc. | Microtest Laboratories, Inc. | Blogs | Comments

I agree that the FDA should regulate mobile medical apps (MMA) because there is a potential that certain apps used to treat and diagnosis disease states can be harmful to patients when not working properly. When the FDA published the current...

Medtronic’s Viva Cardiac Resynchronization Therapy-Pacemaker Approved in U.S.

August 25, 2014 10:26 am | by Medtronic | News | Comments

Medtronic, Inc. has announced the U.S. Food and Drug Administration (FDA) approval of its newest cardiac resynchronization therapy-pacemaker, Viva CRT-P, for indicated patients with heart failure or atrioventricular (AV) block. The Viva CRT-P...

Assessing FDA’s Final Guidance on Companion Diagnostics

August 22, 2014 2:28 pm | by Richard Park, Contributing Editor | Blogs | Comments

On the same day that FDA released its draft guidances on regulating laboratory-developed tests (LDT), the agency also issued a final guidance on the development, review, and clearance of companion diagnostics. According to FDA, this guidance...

Direct Flow Medical’s TAVI Technology Receives Additional CE Mark

August 22, 2014 1:37 pm | by Direct Flow Medical | News | Comments

Direct Flow Medical, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, today announced it has received the CE Mark (Conformité Européenne) for a 23mm sized valve as part of its Direct Flow Medical Transcatheter...

Ultrasound-Based Wound Healing System Receives FDA Clearance

August 21, 2014 10:12 am | by PR Newswire | News | Comments

Celleration, Inc., a privately held medical device company focused on developing and commercializing therapeutic ultrasound healing technologies to treat wounds, has announced they received FDA clearance for their next generation UltraMIST...

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FDA 510(k) Clearance for Philips' TAVI Precision Treatment Planning Application

August 21, 2014 10:03 am | by PR Newswire | News | Comments

Royal Philips today announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market its precision planning application for Transcatheter Aortic-Valve Implantation (TAVI) treatments. Through 3D imaging, the...

First FDA Clearance to Detect a Serious Heart Condition in an ECG on a Mobile Device

August 21, 2014 10:01 am | by PR Newswire | News | Comments

AliveCor, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its algorithm to detect atrial fibrillation (AFib), the most common form of cardiac arrhythmia. AliveCor's automated analysis...

Clinical Trials: Enhancing Data Quality, Encouraging Participation and Improving Transparency

August 20, 2014 2:03 pm | by Margaret A. Hamburg, M.D., Commissioner, FDA | Blogs | Comments

Today FDA is announcing important steps that the agency plans to take to enhance the collection and availability of clinical trial data on demographic subgroups – patient populations divided by sex, race/ethnicity or age. Section 907 of the...

Providing Easy Access to Medical Device Reports Submitted to FDA Since the Early 1990s

August 19, 2014 2:06 pm | by Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director of Office of Informatics and Technology Innovation, FDA and Jeffrey Shuren, M.D., Director – CDRH, FDA | Blogs | Comments

In addition to food and drugs, FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential...

3D Printed Patient-Specific Facial Device Receives FDA Clearance

August 19, 2014 11:26 am | by Globe Newswire | News | Comments

Oxford Performance Materials, Inc., a leading advanced materials and additive manufacturing (3D printing) company, has announced that it has received 510(k) clearance from the FDA for its 3D printed OsteoFab Patient-Specific Facial Device...

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Patent examiners more likely to approve marginal inventions when pressed for time

August 13, 2014 4:02 pm | by EurekAlert! | News | Comments

Haste makes waste, as the old saying goes. And according to research from a University of Illinois expert in patent law, the same adage could be applied to the U.S. Patent and Trademark Office, where high-ranking examiners have a tendency to rubber-stamp patents of questionable merit due to time constraints.

Photos of the Day: Counterfeiting's Breathalyzer

August 7, 2014 4:45 pm | by University of Michigan | News | Comments

Terry Shyu, a doctoral student in chemical engineering at the University of Michigan, was demonstrating a new high-tech label for fighting drug counterfeiting. While the researchers don't envision movie stars on medicine bottles, but they...

A Breath Reveals a Hidden Image in Anti-Counterfeit Labels

August 7, 2014 4:45 pm | by University of Michigan | News | Comments

An outline of Marilyn Monroe's iconic face appeared on the clear, plastic film when a researcher fogs it with her breath. Terry Shyu, a doctoral student in chemical engineering at the University of Michigan, was demonstrating a new high-tech...

FDA Approval for Medtronic’s Attain Performa Quadripolar Lead and Viva Quad CRT-Ds

August 7, 2014 9:47 am | by Medtronic | News | Comments

Medtronic, Inc. has announced it has received United States Food and Drug Administration (FDA) approval for the Attain Performa Model 4298 quadripolar lead, and the Viva Quad XT and Viva Quad S cardiac resynchronization therapy defibrillators...

UDI: A Nonstandardized Test for Manufacturers

August 5, 2014 4:23 pm | by Karen Conway, Executive Director, Industry Relations, GHX | Blogs | Comments

The underlying purpose of the U.S. FDA’s Unique Device Identification (UDI) Rule seems simple enough: to “adequately identify medical devices through distribution and use.” But even manufacturers that have been working for years – some even...

Curbing Risk, Not Medical Innovation, in Personalized Medicine

August 4, 2014 3:55 pm | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Blogs | Comments

Innovative new tests are routinely submitted to the Food and Drug Administration to assure they are safe and effective. They include genetic tests that help oncologists decide whether a patient is a good candidate for a drug that treats melanoma...

Breaking Down the Regulation of LDTs: Moving Forward

August 4, 2014 3:29 pm | by Richard Park, Contributing Editor | Blogs | Comments

The letter stated that in order to move toward equal regulation, FDA should share its thinking on what it believes LDT regulation under FDCA should look like in practice, or how it plans to deregulate IVDs, by releasing its draft guidance...

FDA Takes Steps to Help Ensure the Reliability of Certain Diagnostic Tests

August 4, 2014 8:20 am | by FDA | News | Comments

The U.S. Food and Drug Administration has taken important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results. First, the FDA is issuing a final...

Test To Screen Donors of Blood, Tissues, and Organs for Hepatitis E Virus Receives CE Mark

July 24, 2014 2:27 pm | by Grifols | News | Comments

Grifols, one of the world’s leading companies in the plasma-derived biological medicines and transfusion medicine sectors, has announced CE mark for the Procleix HEV assay. The test, developed in collaboration with Hologic, Inc. (HOLX)...

A Curriculum for Medical Device Progress

July 22, 2014 3:44 pm | by Francis Kalush, Ph.D., senior science advisor, Center for Devices and Radiological Health, FDA | Blogs | Comments

Horace, the greatest Roman poet of antiquity, spoke of the need to “seek for truth in the groves of Academe” — and in the last four years, my colleagues in FDA’s Center for Devices and Radiological Health (CDRH) and I took his advice. In...

Two UL Battery Safety Standards Are Now FDA Recognized Consensus Standards for Medical Devices

July 22, 2014 9:18 am | by PR Newswire | News | Comments

UL (Underwriters Laboratories), a global safety science leader, has announced that the U.S. Food and Drug Administration (FDA) has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium...

FDA Approval for Boston Scientific’s REBEL Platinum Chromium Coronary Stent System

July 22, 2014 9:06 am | by PRNewswire | News | Comments

Boston Scientific Corporation has received FDA approval for the REBEL Platinum Chromium Coronary Stent System, the company's latest generation bare-metal stent for the treatment of coronary artery disease (CAD). Bare-metal stents continue...

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