Recent progress on demographic information and clinical trials
February 19, 2015 by MassDevice
At FDA, one of our foremost responsibilities is to evaluate and if medical products meets the appropriate standard, to approve or clear drugs, biological products and medical devices. We know that these products are safer and more effective for everyone when they are tested in clinical trials that include diverse populations.
The design and analysis of clinical trials has evolved significantly over the last three decades. FDA now has a variety of statutory, regulatory, and policy-related tools at its disposal that provide a framework for guiding medical product sponsors and FDA review teams in the collection, subset analyses, and communication of these data. Read more
Moving toward a national medical device postmarket surveillance system
February 23, 2015 by MassDevice
Despite rigorous premarket evaluation, what really counts is how well a medical device works when it’s used day-to-day by patients, caregivers and clinicians. Beyond clinical trials, real-life patient experience may reveal unanticipated device risks and confirm long-term benefits.
Similar to other medical products such as drugs or vaccines, medical devices offer vital, sometimes life-saving, benefits, but they must be balanced against certain risks. A strong postmarket surveillance system can provide more robust and timely benefit-risk profiles for devices so that providers and patients can make better informed health care decisions. Read more
Medtronic wins CE Mark for Euphora Semicompliant balloon catheter
February 17, 2015 by Mark Hollmer
Medtronic is launching another iteration of its Euphora coronary balloon dilation catheter in Europe – a product designed to make sure implanted drug-eluting stents are effectively placed in the body.
The Fridley, Minn.-based medical device giant said it’s rolling out the Euphora Semicompliant balloon dilation catheter, having won CE Mark approval in the European Union. It is designed to help physicians determine blockages, the selection of an ideal stent type and facilitate stent access to lesions, Medtronic said. Read more
Simplify Medical wins CE Mark for MRI-safe cervical disc
February 17, 2015 by Mark Hollmer
California’s Simplify Medical said it won CE Mark approval in the European Union for a cervical artificial disc that’s safe for MRI use, and is now shifting its focus to the U.S. regulatory approval process.
The Mountain View-based company said its Simplify Disc is made of MRI-friendly, non-metal materials such as medical polymers and ceramic designed to help patients reduce radiation exposure and avoid invasive CT scans. Read more
