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. St. Jude Medical’s MultiPoint pacing tech wins FDA approval
St. Jude Medical said the FDA approved its MultiPoint pacing technology for its Quadra Allure defibrillators and pacemakers, plus a new set of quadripolar pacing leads called Quartet LV.
The Little Canada, Minn.-based medical device company said the MultiPoint tech is the 1st to hit the U.S. market that allows physicians to tailor pacing therapy by controlling multiple pulses to the left ventricle for each heartbeat. Each lead in the system can deliver 2 pulses per heartbeat, St. Jude said. Read more
2. FDA expands approval for Medtronic’s deep-brain stimulation for Parkinson’s
Medtronic said that it won expanded approval for its deep-brain stimulation therapy for patients with Parkinson’s disease, which 1st won approval from the safety watchdog in 2002.
The expanded approval covers patients who have had a Parkinson’s diagnosis for 4 years and recently developed motor complications, or have long-standing motor complications that can’t be controlled with drugs. The original FDA approval for Medtronic’s DBS for Parkinson’s covered patients in the advanced stages of the disease, the Fridley, Minn.-based company said. Read more
1. Shareholder seeks class action in lawsuit against Cardiovascular Systems
A Cardiovascular Systems shareholder filed a purported class action lawsuit, accusing the medical device company and its management of misleading investors about an alleged off-label promotion scheme she claims spurred a -70% plunge in the value of CSI’s stock.
“Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (1) CSI distributed illegal kickbacks to health care providers; (2) CSI engaged in the off-label promotion of its medical devices; and (3) CSI violated the Food & Drug Administration’s laws and regulations in connection with its medical devices. As a result of the foregoing, the company’s public statements were materially false and misleading at all relevant times,” plaintiff Caroline Paradis alleged in a lawsuit filed in the U.S. District Court for Central California. Read more
The post MassDevice.com +3 | The top 3 medtech stories for February 17, 2016 appeared first on MassDevice.
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