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Boston Scientific ordered to hand over $18.5M in vaginal mesh litigation

Less than a week after Boston Scientific lost its second courtroom battle over vaginal mesh implants, a federal jury ordered the company to pay $18.5 million in damages to four women who claimed the devices caused them constant pain and injuries.

Smartphone apps to assess mental health based on everyday behavior proliferating

Diagnostic smartphone apps are proliferating. No, these apps don't somehow turn the phone into a needle for drawing blood; instead they monitor stuff we take for granted, like talking or the movement of our eyes.

Tandem partners for open-source software to improve insulin pump data access

Tandem Diabetes Care, the maker of the t:slim insulin pump, has partnered with open-source software provider Tidepool. The deal is expected to better enable diabetes patients using the pump to download and access data from their device.

FDA delays UDI labeling requirements by two years for some orthopedic devices

The FDA originally proposed requiring implantable medical devices to bear a unique device identification code on their surface. But industry protested that part of the proposed rule, so the agency ultimately opted to rely on packaging as the surface for UDIs. However, some orthopedics are removed from their packaging well before surgery or implantation, forcing the FDA to make a change on the fly.

Packaging, software issues account for 40% of medical device recalls, report finds

The Q3 2014 Stericycle Recall Index highlights the complexities of medical device recalls in a global economy. With greater technology comes greater responsibility to consumers, and recalls that span different countries and continents add to companies' challenges. Packaging and software issues accounted for 40% of recalls that the Index covered.

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