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. Report: Toshiba to sell entire medical equipment biz
Toshiba reportedly plans to sell its entire medical equipment unit, Toshiba Medical Systems, rather than just a controlling stake, setting the stage for an aggressive bidding war that could drive the purchase price much higher than the $3.5 billion initial estimate.
A bidding war for a majority share in Toshiba Medical business was already heating up earlier this month among a slew of private equity players and rival corporations, as the Japanese industrial conglomerate sought outside investors. Also this month, Toshiba said it would either shut down or transfer all of its other healthcare businesses by the end of March. Read more
2. FDA mandates new study, ‘black box’ label for Bayer’s Essure
The FDA said it would put a pair of measures in place for the controversial Essure permanent contraception device made by Bayer, mandating a new clinical study and new guidance on using the device.
Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said last year that in the 13 years since Essure’s approval, the agency had received 5,093 complaints, including for pain or menstrual irregularities after using the device, and complaints of the device breaking. In addition to 5 fetal deaths, there were 4 reports of adult deaths for reasons such as infection and uterine perforation, the FDA said. Read more
1. Vascular Solutions, CEO Root beat criminal charges in off-label promotion case
A federal jury acquitted Vascular Solutions and CEO Howard Root of charges that they ran an off-label promotion scheme for its now-discontinued Vari-Lase varicose vein treatment.
A grand jury in the U.S. District Court for Western Texas indicted Maple Grove, Minn.-based Vascular Solutions and Root in November 2014, alleging that they created a “Short Kit” version of the Vari-Lase device after an unidentified competitor won FDA clearance for a radiofrequency ablation device to treat perforator veins, because Vari-Lase was only cleared for treating superficial veins. Read more
