FDA
Mobile Health Funding Doubled Last Year Despite Tight Capital Markets
Feb 07, 2012
Although there has been some improvement in capital markets, access to capital is still a central concern in 2012, said G. Steven Burrill, CEO of venture...
Survey: Majority of Biomedical Companies Cutting R&D Projects
Jan 11, 2012
On January 10, PricewaterhouseCoopers, the California Healthcare Institute, and BayBio released preliminary findings of its California Biomedical Industry 2012...
Medtronic Launches Remote Glucose Monitor
Jan 06, 2012
Medtronic Inc. announced FDA approval and U.S. market launch of the first-of-its-kind mySentry Remote Glucose Monitor, which allows a parent or caregiver to...
FDA Is Now Blogging
Jan 03, 2012
Just before Christmas, FDA debuted a new blog named "FDA Voice." The inaugral post was written by FDA administrator Margaret Hamburg, who...
When Reason Meets the Absurd: A Quick Look at FDA and CDRH in 2011
Dec 18, 2011
While FDA (CDRH) and the medical device industry have a long history of antagonism, the relationship seemed to become especially sour in 2011. The agency has...
The Roadblock May Not Be the FDA After All
Dec 16, 2011
A colleague and I visited with a startup company last week, one that was designing a product that can detect certain ailments through your breath. Named...
Medical Device Gets Regulatory Nod in 17 Days
Dec 15, 2011
Robert Perry, MD, a resident at University of Oklahoma Medical Center, has developed a simple device to help clinicians locate vasculature. The EZ Vein device...
Misunderstanding of FDA Device Classification Is Widespread
Dec 09, 2011
The device classification scheme is an important component of the U.S. regulatory system for medical technology. Introduced in the Medical Device...
This Week in Devices: Qualcomm Steps Up its Wireless Health Involvement
Dec 09, 2011
This week in devices, a Minnesota trade group signed a deal with CDRH to speed device approvals and MD+DI's full salary survey results were released. Also,...
Why Don't CDRH Reviewers Always Greet You Warmly on the Phone? They Are Stressed, Says Former FDA Insider
Dec 06, 2011
At a conference session at Biomedevice at San Jose, president of CardioMed Device Consultants (Baltimore) Semih Oktay, PhD gave a broad overview of CDRH ...