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. Philips wins FDA nod for BlueControl psoriasis treatment device
Royal Philips said today it won FDA 510(k) clearance for its BlueControl wearable light therapy designed to treat mild psoriasis.
The Amsterdam-based company’s BlueControl is designed as a rechargeable, wearable device which can be comfortably used on the arms, legs, elbows and knees using adjustable straps. The company won CE Mark approval in the European Union for the device in 2015. Read more
4. Avita to seek PMA for ReCell burn indication, considers making US operations hub
Avita Medical today released an update on its future plans, saying it it intends to submit an application to the FDA for Premarket Approval for its ReCell device for use in patients with severe burns and that it’s considering making the US its center of operations.
The ReCell device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the company said. Read more
3. Bigfoot Biomedical taps Abbott to collaborate on automated insulin delivery tech
Abbott and Bigfoot Biomedical said today that the companies inked a deal to develop and commercialize diabetes management systems.
The collaboration will bring together Abbott’s FreeStyle Libre glucose monitoring tech and Bigfoot’s insulin delivery platform, the companies reported. Read more
2. Court reaffirms Stryker’s $248m enhanced damages win in Zimmer Biomet patent spat
Stryker has been awarded an enhanced $248 million ruling in a surgical tool patent case against Zimmer Biomet, due to a US Supreme Court ruling which made it easier to award enhanced damages, according to court documents released yesterday.
Western District of Michigan Judge Robert Jonker reaffirmed an earlier decision to award enhanced damages “in light of the Supreme Court’s clarification of the governing standard in Halo Electronics, Inc. v. Pulse Electronics, Inc.,” according to court documents. Read more
1. US House passes medical device user fee agreement
The US House of Representatives today passed a bill to reauthorize the FDA’s medical device user fee program, alongside a prescription drug, generic drug and bio similar programs through 2022.
Newly appointed FDA commissioner Scott Gottlieb applauded the passage, saying it was a “timely reauthorization key for FDA, patients,” on Twitter after the bill passed. Read more
