3M expects to complete the spinoff of its healthcare business during the first half of 2024. During 3M’s Q3 earnings call today, CEO Mike Roman said the spinoff is progressing. He mentioned the previous news of leadership hires for the new stand-alone company, including former Zimmer Biomet CEO Bryan Hanson as CEO and former Humacyte […]
How Imperative Care seeks to change the game in stroke treatment
With a new organizational structure meant to accelerate growth, Imperative Care is seeking to improve care even more for people with strokes and other ischemic diseases. There is an urgent need for better stroke care. Strokes hit a new person every 40 seconds in the U.S. — and kill someone about every 3 minutes, according […]
FDA clears DePuy Synthes TriLeap plating system for foot and ankle surgeries
DePuy Synthes, the orthopedic device business of Johnson & Johnson , has won FDA 510(k) clearance for its TriLeap lower extremity anatomic plating system. The company said it designed the TriLeap system to address the intricate needs of orthopedic surgeons and foot and ankle specialists. As conditions like bunions become more prevalent —with Cleveland Clinic […]
Outset Medical stock plummets amid warning letter woes
Outset Medical has slashed its full-year revenue outlook as the maker of Tablo hemodialysis systems grapples with an FDA warning letter. The company now expects roughly $130 million in revenue in 2023 — down from its previous forecast of $144–150 million. It’s preliminary numbers show third-quarter sales up 9% year-over-year to $30.4 million. Cash, cash […]
What’s next for Abbott’s cardiovascular business?
Abbott boosted its vascular device offerings even more with its acquisition of Cardiovascular Systems this year. Wondering what comes next? Abbott Vascular President Julie Tyler will explain at our DeviceTalks West event, Oct. 18–19 in Santa Clara. (Register here.) Even as COVID-19 test sales continue to decline and hammer overall revenue, Abbott officials are betting […]
Judge grants preliminary approval to Philips class action settlement
A federal judge in Pennsylvania has granted preliminary approval to an economic loss settlement involving lawsuits filed against Philips over its massive recall of CPAPs and other respiratory devices. U.S. District Court Judge Joy Flowers Conti’s order, filed yesterday, could just be the beginning of settling what has arguably been one of the medical device […]
Getinge makes infection prevention play with Healthmark buy
Getinge announced today that it has acquired Healthmark Industries, a Fraser, Michigan–based provider of instrument care and infection control consumables. The Swedish medtech company paid $320 million in cash for 100% of Healthmark. The acquisition aims to bolster Getinge’s footprint in the U.S. sterile reprocessing market while paving the way for Healthmark’s global expansion. The […]
Boston Scientific wins expanded indication for SCS system
The FDA has greenlit an expanded indication for the WaveWriter Alpha spinal cord stimulator systems from Boston Scientific . The approval now includes the treatment of painful diabetic peripheral neuropathy, a diabetes complication affecting the lower extremities. Diabetic neuropathy, a form of nerve damage often found in the legs and feet, is caused by prolonged […]
How Intuitive plans to continue its surgical robotics leadership
Companies large and small have sought to take on Intuitive in soft-tissue surgical robotics, but it has maintained its dominance. Intuitive President Dave Rosa will explain how Intuitive plans to continue maintaining distance from its competitors — and much more, during DeviceTalks West next week. Register here for the event, which is Oct. 18–19 in […]
Philips reportedly withheld CPAP problems from the FDA for years
Philips received the first complaints of degraded sound abatement foam in its respiratory devices in 2010, but 11 years passed before it turned into a major recall, according to a ProPublica and Pittsburgh Post-Gazette investigation published today. According to ProPublica, Philips withheld the vast majority of the warnings about black particles, dirt, dust and other […]
MedTrace raises $19M for its PET-boosting technology
MedTrace Pharma announced today that it has raised €18.2 million (roughly $19 million) to fund the completion of its Phase 3 trial of its tech to make PET with oxygen-15 labeled water widely available. 15 O-water has a reputation as a gold-standard radioactive tracer for PET imaging, but supply chain problems around the substance have hindered […]