Regulatory
Sequenom Disputes FDA Letter on Genetic Test
Companies have had varying responses to FDA's recent investigation of genetic tests. MD+DI columnnist Jim Dickinson adds:   San Diego-based Sequenom says it is disputing a recent FDA untitled letter seeking regulatory approval or clearance of the company’s genetic test....
Advisory Panels Schedule for Remainder of 2010
Several FDA advisory committees are meeting before the year is out to discuss and make recommendations on a variety of products and issues. The meetings concerning medical devices are listed below: RADIOLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE DATE: Sept...
FDA Backs Risk-Based Approach for Lab Tests
CDRH says moving forward with a risk-based approach for providing regulatory oversight over laboratory-developed and commercially marketed tests will help assure physicians and consumers that test results are reliable. Speaking at a July 19 FDA public meeting in Hyattsville, MD,...
FDA's Town Hall Tour Comes to the West Coast
Got something to say to FDA? If you live in California, you just might be in luck. From FDA: The meeting will be held on October 7, 2010, beginning at 8:00 a.m., at the following location: Hilton Irvine/Orange County Airport Hotel 18800 MacArthur Blvd Irvine, CA 92612 Phone: (...
Japan Welcomes Zoll AEDs
Zoll Medical's automated external defibrillators (AEDs) will soon be imported and distributed in Japan. The Japanese Pharmaceutical and Medical Devices Agency granted approval to Zoll's AED Plus and AED Pro. Both technologies will be the only AEDs available in Japan that have real-...
Contact Lenses Lead to Medical Injuries in Kids
According to a new study led by Cunlin Wang, MD, an epidemiologist in the Office of Surveillance and Biometrics at FDA, more than 70,000 children are sent to emergency rooms a year as a result of using medical devices, such as contact lenses. The analysis is online in the journal...
FCC and FDA to Coregulate Wireless
The Federal Communications Commission and FDA signed a memorandum of understanding (MOU), agreeing that that the agencies will work together to create an efficient regulatory structure for wireless-enabled medical devices and services. The agreement has a five-year sunset...
Software Defects Potentially Deadly
A report from the Software Freedom Law Center says that source code defects in implantable medical devices could be result in a life-or-death situation for its users. In the report, "Killed by Code: Software Transparency in Implantable Medical Devices," SFLC advocates free...
AAMI Honors Medtech Contributors
AAMI awarded nine professionals in the device industry for their contributions to medical technology. See the list below: AAMI Foundation Laufman-Greatbach Prize—Neal E. Fearnot, PhD, founder and president of the MED Institute and Cook Biotech Inc. both based in West...
AdvaMed Spends for Medtech Industry
According to financial filings, AdvaMed spent $385,000 in the first quarter of 2010 lobbying Congress on behalf of the medtech industry. The organization's efforts were spurred by several significant issues. The first is healthcare reform, which dominated headlines for months....