April 21, 2015 by Brad Perriello
An FDA panel last week issued its recommendations for pre- and post-market studies of flow diverters used to treat brain aneurysms.
The safety watchdog’s neurological devices panel met April 17 to discuss flow diverters, also known as coil embolization devices, which work by diverting blood flow away from aneurysms including large or wide-necked aneurysms. The FDA is not bound by its advisory panels’ recommendations but often follows their lead. Read more
April 24, 2015 by Brad Perriello
A new Senate bill introduced yesterday would create a fast-track program at the FDA for breakthrough medical devices
The bill, S. 1077 or " A bill to provide for expedited development of and priority review for breakthrough devices," was sponsored by Sen. Richard Burr (R-N.C.) and co-sponsored by Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.). Read more
April 22, 2015 by Brad Perriello
Medtronic said that it won European approval for full-body MRI scans of patients implanted with its Activa deep-brain stimulation device.
The Fridley, Minn.-based medical technology giant said the expanded approval applies to patients receiving the Activa implant for the 1st time, plus some 13,000 European patients already implanted with Medtronic DBS devices. Read more
April 23, 2015 by Brad Perriello
Siemens Healthcare said the FDA approved a new breast tomosynthesis option for its Mammomat Inspiration digital mammography device.
Malvern, Pa.-based Siemens Healthcare said its BT algorithm compiles 2-dimensional breast images into a 3-dimensional construct “to enable detection of tumors that are hidden by overlapping breast tissue.” Read more
April 27, 2015 by Brad Perriello
The FDA issued a Class I recall of the TigerPaw II device Getinge subsidiary Maquet Cardiovascular acquired in 2013.
The recall, which affects some 4,154 of the TigerPaw II left atrial appendage closure devices, follows an increase in reports of torn tissue on the left atrial wall and bleeding during use of the device, the FDA said. Read more