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.
Get this in your inbox everyday by subscribing to our newsletters.
Alere yesterday said that it’s suing to force the Centers for Medicare & Medicaid Services to reinstate its Arriva diabetes division’s enrollment, after the government health insurer yanked the accreditation last month over issues with an excess of claims submissions for deceased patients.
Arriva, which develops durable medical equipment for diabetic testing, was informed Oct. 12 that its Medicare enrollment would be revoked by CMS, which said at the time that Arriva submitted claims for 211 deceased patients. Alere attempted to appeal the determination, but the appeal was denied Nov. 2 and the group’s enrollment in CMS was revoked 2 days later. Read more
Intarcia Therapeutics said today that it raised a $206m Series EE round and inked a deal with the Bill & Melinda Gates Foundation to fight HIV in emerging nations.
It’s the 2nd of 3 tranches in an ongoing round for Intarcia, which is developing a drug-delivery platform called Medici, a match-sized osmotic pump designed to be placed under the skin during an in-office procedure. The 1st tranche in September brought in $215 million. Read more
A federal appeals court yesterday resuscitated a shareholders lawsuit accusing Medtronic of concealing for nearly 10 years the negative side effects of its Infuse bone growth protein.
The U.S. Court of Appeals for the 8th Circuit said a lower court judge was wrong to find that the plaintiffs sued too late, by waiting more than 2 years after learning of the alleged intent to defraud. The plaintiffs include institutional investors West Virginia Pipe Trades Health & Welfare Fund, Union Asset Management Holding AG and Employees’ Retirement System of Hawaii. Read more
Minerva Surgical reported a funding round worth $16.7 million and said it wants to raise $10 million more.
Redwood City, Calif.-based Minerva, founded in 2008, is developing technologies for treatment of abnormal uterine bleeding. Its flagship device is the Aurora endometrial ablation system, which targets and eliminates the endometrial lining in a procedure that takes as little as 4 minutes. The device won pre-market approval from the FDA in July 2015. Read more
A federal appeals court last week dismissed a whistleblower lawsuit filed by a former sales rep for Medtronic subsidiary Ev3, ruling that the allegations weren’t strong enough to sustain a False Claims Act suit.
Whistleblower Jeffrey D’Agostino in October 2010 filed a qui tam lawsuit alleging that Ev3 violated the FCA by promoting its Onyx hydrogel blood blocker and Axium embolization coil for off-label uses. Judge Richard Stearns of the U.S. District Court for Massachusetts dismissed the suit in September 2014, ruling that D’Agostino failed to produce sufficient evidence to prove his allegations, after denying the plaintiff’s bid to file a 4th amended complaint. Read more