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. Shareholders sue Edap following FDA slip
A law firm is gathering support for a class action lawsuit against Edap TMS, accusing leadership of misleading investors after an FDA expert panel panned the company’s flagship ablation technology.
EDAP shares have lost more than 65% over the last month after the FDA’s Gastroenterology & Urology Devices panel voted against recommending approval for the Ablatherm ultrasound ablation system for treatment of prostate cancer. The panel voted unanimously that the device did not appear to be effective and in majority that the technology was not safe. Read more
2. St. Jude Medical says FDA clears Texas neuromodulation plant
St. Jude Medical said today that the FDA cleared it of manufacturing violations at a Plano, Texas, plant the watchdog agency flagged in a 2009 warning letter. It’s the 2nd such letter to be cleared by the watchdog agency in as many months.
The Plano facility was acquired when St. Jude paid $1.3 billion for Advanced Neuromodulation Systems in 2005. In 2007, St. Jude initiated a field action after discovering software and hardware defects in some of its Eon spinal cord stimulation devices intended to treat chronic pain, according to the warning letter. Read more
1. Medtronic buys out NGC Medical in $350M deal
Medtronic said that it bought out the remaining 70% share of NGC Medical SpA in a deal valuing the Italian hospital management provider at $350 million.
NGC Medical manages the cardiovascular suites, operating rooms and intensive care units at nearly 30 hospitals in Italy and is “rapidly expanding its service offerings throughout Europe, the Middle East and Africa,” according to a press release. Medtronic had owned a 30% stake in NGC, according to the release, and plans to have it serve as its managed services operation in its hospital solutions segment. Read more
