Minnesota medical device maker Advanced Circulatory Systems won a panel date with the FDA to review a PMA bid for its ResQCPR resuscitation systems.
Resuscitation
Google Glass – the details
The making of an icon | Dr. Tom Fogarty’s ‘Fog Shop’
It’s been 50 years since Dr. Tom Fogarty invented the catheter-based treatment for blood clots that’s now the standard of care. At 80, it would be a cinch for Fogarty to retire to his California vineyard and bask in the reflected glory of his accomplishments.
MassDevice.com +3 | The top 3 med-tech stories for Mar. 6, 2014
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
Another Class I recall for GE Healthcare
Federal healthcare regulators put their highest-risk Class I label on a new warning issued over GE Healthcare’s (NYSE:GE) Giraffe and Panda neonatal infant warmers and resuscitation systems.
Medical device recalls for February 2014
February Summary
Class I recalls: 30
Class II recalls: 170
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
14 health care innovation predictions for 2014
By Vector Staff
2013 saw an accelerated crumbling of borders and boundaries in health care, fueled by technological and scientific advances. Boundaries between high-tech Western medicine and global health practices have begun blurring in interesting ways, as are those between home and hospital, patient and doctor and even a patient’s own body and the treatment used for her disease.
Medtronic’s guidewire recall gets FDA’s highest-risk label | MassDevice.com On Call
MASSDEVICE ON CALL — Medical device titan Medtronic (NYSE:MDT) announced late last week that the FDA had put its highest-risk label on a company recall of certain guidewires. The agency deemed the recall a "Class I" issue, reserved for device defects that could "cause serious adverse health consequences or death."
DNR orders and end-of-life decisions for children: The elephant in the room
Amy Sanderson, MD, is a critical care physician at Boston Children’s Hospital whose research interests include developing and studying interventions to improve the quality of communication among clinicians, parents and children with life-threatening illnesses.
FDA panel recommends reducing regulatory burden on cardiac devices
A panel of experts yesterday recommended the FDA down-classify several types of cardiac devices from the high-risk Class III category to the less-stringent Class II.
Medical device recalls for August 2013
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall