Say hello to MassDevice +3, a bite-sized view of the top three medtech 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.
3. ReCor Medical to launch U.S. trial for Paradise renal denervation device
ReCor Medical said that it won an investigation device exemption from the FDA for a clinical trial of its Paradise renal denervation device for treating high blood pressure.
Palo Alto, Calif., and Amsterdam-based ReCor said the 292-patient Radiance-HTN study, a blinded, randomized and sham-controlled trial, is designed to evaluate the Paradise system in patients with essential hypertension taking 2 or fewer medications and patients with treatment-resistant hypertension on a minimum of 3 drugs. Read more
2. FDA panel votes against Medtronic’s DIAM spine stabilization system
An FDA advisory panel reportedly recommended against approval for the DIAM spinal stabilization system made by Medtronic.
The federal safety watchdog’s Orthopaedic & Rehabilitation Devices panel met Feb. 19 to consider the pre-market approval application for DIAM, which stands for “device for intervertebral assisted motion.” It’s designed to treat lower back pain from moderate lumbar degenerative disc disease, at a single level from the L2 to the L5 vertebrae. The system is designed to act as a shock absorber for the vertebrae, placed between the spinous processes. Read more
1. Medicare contractor won’t cover St. Jude Medical’s CardioMEMS heart monitor
A Medicare contractor said it would not cover the CardioMEMS implantable heart monitor made by St. Jude Medical, citing the need for more clinical data on the device.
Novitas, a Medicare Administrative Contractor that covers patients in Pennsylvania, New Jersey, Maryland, Delaware, Colorado, Oklahoma, New Mexico, Texas, Arkansas, Louisiana, Mississippi and and Washington, D.C., said it would not cover the CardioMEMS device, which is designed to monitor patients for signs of heart failure. Read more
The post MassDevice.com +3 | The top 3 medtech stories for February 22, 2016 appeared first on MassDevice.
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