Diabetes: FDA OKs new 'artificial pancreas' software for DexCom glucose meter

November 6, 2014 by Brad Perriello

Dexcom Inc. said today that the FDA approved new “artificial pancreas” software for its G4 Platinum continuous glucose monitor.

San Diego-based DexCom said its new Software 505 “features the same advanced algorithm as used in artificial pancreas research around the world.” Read more

FDA: Edap's Ablatherm prostate cancer device 'not approvable'

November 6, 2014 by Brad Perriello

EDAP said today that the FDA sent it a “not approvable” letter over the Ablatherm prostate cancer treatment it’s trying to get approved for the U.S. market.

But the federal watchdog agency’s Center for Devices & Radiological Health left the door open for another run at pre-market approval, the French medical device maker said, recommending a narrower indication for Ablatherm. Read more

Cardiovascular Systems wins CE Mark for Stealth 360 peripheral artery device

November 5, 2014 by Val Kennedy

Cardiovascular Systems said it received CE Mark clearance for its Stealth 360 orbital atherectomy system for the treatment of severe peripheral artery disease.

The system consists of a catheter with a rotating crown that “sands” down plaque deposits to help restore blood flow in limbs affected by PAD. Read more