Medtronic wins HDE for Enterra II neurostim device

January 23, 2015 by Brad Perriello

Medtronic today said it won a humanitarian device exemption for its Enterra II device, a neurostimulation implant designed to treat the stomach disorder gastroparesis.

The stomach muscles of patients with gastroparesis function poorly or not at all, preventing it from emptying and interfering with digestion. The Enterra II device is designed to treat the nausea and vomiting that often accompanies gastroparesis in patients who can’t take drugs to treat the condition, Medtronic said, noting that about 5% of diabetics are estimated to suffer from gastroparesis. Read more

FDA officially clears Integra's Puerto Rico plant

January 20, 2015 by Brad Perriello

The FDA officially cleared Integra LifeSciences of violations at a plant in Puerto Rico that led to a warning letter back in February 2013.

The FDA issued a Form 483 after inspections in the fall of 2012 turned up process validations and inadequate systems for corrective and preventative actions and document controls. Read more

Nevro surges on Senza approvable letter from FDA

January 23, 2015 by Brad Perriello

Shares of Nevro Corp. surged nearly 17% today after the company said it received an “approvable letter” from the FDA for its Senza spinal cord stimulator for chronic pain, signaling a sooner-than-expected approval for the U.S. market.

The Senza device is designed to deliver up to 10,000Hz to the spinal cord; Nevro says previous trials demonstrated that its HF10 therapy is nearly twice as successful in treating back pain as traditional SCS devices, which typically deliver between 40Hz and 60Hz. Read more

mHealth: AliveCor wins CE Mark for new afib algorithm

January 23, 2015 by Mark Hollmer

AliveCor said it plans to launch the latest version of its app to detect atrial fibrillation in the U.K. and Ireland after winning CE Mark approval in the European Union for the updated tech.

San Francisco-based AliveCor said the CE Mark is for an automated analysis process algorithm used in the updated version of its AliveECG app. Among the new bells and whistles: Analysis of each electrocardiogram recording by way of the company’s heart monitor, with real-time, automatic notification to the user if atrial fibrillation is detected. Read more

FDA warns against pediatric use of bone growth proteins

January 22, 2015 by Mark Hollmer

The FDA this week warned healthcare providers against using 2 types of bone-growth materials in patients under age 18 who have bone growth defects.

“The FDA is aware of healthcare providers using bone graft substitutes containing recombinant proteins or synthetic peptides in patients under age 18,” the watchdog agency wrote in the Jan. 21 “safety communication.” Read more