Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
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5. FDA approves Valencia’s eCoin neurostim trial
Valencia Technologies said today it won investigational device exemption approval from the FDA to begin a trial of its eCoin neurostimulator for treating drug-resistant hypertension.
The company is slated to pick up 300 patients on at least 3 antihypertensive drugs for a trial of the coin-sized device, which is designed to be placed in the forearm during a short in-office procedure under local anesthesia. Read more
4. BD, Apax Partners close Vyaire respiratory JV deal, tap ex-Tornier chief Mowry for CEO
Becton Dickinson & Co. said today it finalized the launch of a respiratory solutions joint venture with Apax Partners under the Vyaire Medical brand.
The deal, which the companies announced in March, will put a controlling 50.1% of BD’s respiratory solutions business under the control of the private equity shop, and put former Tornier chief exec & ex-Wright Medical COO Dave Mowry in the corner office of the new JV. Read more
3. FDA approves St. Jude Medical’s BurstDR spinal cord stimulation for chronic pain
St. Jude Medical said today that the FDA granted pre-market approval for its BurstDR spinal cord stimulation technology, which is designed to mimic the body’s natural nerve-firing patterns to optimize SCS treatment for chronic pain.
The BurstDR technology is available with new implantations of St. Jude’s Proclaim Elite and Prodigy MRI SCS devices; it will also be available “soon” as a non-surgical upgrade to already-implanted Protégé and Proclaim SCS systems, Little Canada, Minn.-based St. Jude said. Read more
2. Boston Scientific loses bid to toss $19m pelvic mesh loss
Boston Scientific yesterday lost its bid to overturn an $18.5 million loss in a product liability lawsuit brought by a quartet of women alleging that its Obtryx pelvic mesh caused their injuries.
A jury in West Virginia federal court in November 2014 found Boston Scientific liable to 4 women following a 10-day trial; the trial judge later ordered the Marlborough, Mass.-based company to pay each of the 4 women damages ranging from $3.25 million to $4.25 million (the 4th plaintiff later settled her case out of court and it was dismissed). Read more
1. Johnson & Johnson warns on low cyber risk with Animas OneTouch Ping insulin pump
Johnson & Johnson is reportedly warning patients of a small risk that hackers will target its Animas OneTouch Ping insulin pump, after learning of the bug causing the potential cybersecurity risk.
There haven’t been any reports of actual attempts to hack the Animas OneTouch Ping device, company executives told Reuters about what’s believed to be the 1st instance of a medical device company warned patients about the potential for a malicious hacking attack. Read more
