TriReme touts FDA okay for more Chocolate PTA balloon catheters
Food & Drug Administration (FDA)
Leaked Fresenius memo spurs FDA probe | Legal News
FDA investigators want answers from Fresenius (NYSE:FMS) after a dialysis website leaked a copy of an internal memo released to the company’s in-house dialysis centers.
The memo detailed adverse events possibly associated with improper use of its Granuflo dialysis concentrate, including a possible 5-fold increase in heart-attack risk associated with the compound.
U.K. settles cancer risk for substandard breast implants | MassDevice.com On Call
MASSDEVICE ON CALL — A U.K. researcher tasked with defining the health risk for the nearly 50,000 women who were given substandard implants concluded that the devices were unlikely to cause long-term health problems.
The implants were pulled from shelves amid quite a kerfuffle last year when investigators discovered that Poly Implant Prosthèse was using industrial grade silicon, rather than medical grade.
MassDevice.com +3 | The top 3 med-tech stories for June 18, 2012.
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.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
FDA releases April 2012 PMA approvals
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 120
Summary of PMA Originals Under Review
Total Under Review: 66
Total Active: 29
Total On Hold: 37
Number Greater Than 180 Days: 1
FDA clears St. Jude’s Amplatzer catheter-based vascular plug | Regulatory Roundup
Eurozone med-tech makers lament a new PMA device review process | MassDevice.com On Call
MASSDEVICE ON CALL — A clutch of European medical device makers lamented the European Parliament’s vote in favor of a new pre-market authorization system for medical devices that the med-tech makers say create "years of delay in the availability of medical technology solutions to European citizens."
MassDevice.com +7 | The top 7 med-tech stories for the week of June 11, 2012
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
Some thoughts on the subcutaneous implantable cardiac defibrillator
Diabetes: Dexcom wins European approval for continuous glucose monitor | Regulatory Roundup
FLASH: FDA panel backs Edwards’ Sapien heart valve for lower-risk patients
The FDA’s Circulatory Devices panel recommended expanded approval for Edwards Lifesciences‘ (NYSE:EW) Sapien heart valve to include a lower-risk group of patients, voting 11-0 in favor of approval with 1 panelist not voting.