There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s a Philips recall timeline. Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could […]
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Edwards Lifesciences beats the Street in Q1 and increases sales outlook
Edwards Lifesciences reported first-quarter results that exceeded Wall Street expectations after market close today. The maker of catheter-delivered heart implants — including transcatheter aortic valve replacement (TAVR) systems and transcatheter mitral and tricuspid therapies (TMTT) — also increased its full-year sales guidance. EW’s stock price was relatively flat in after-hours trading. Irvine, California–based Edwards Lifesciences […]
Integer stock sinks despite Q1 beat as full-year forecast disappoints
Integer stock declined by 10% today despite posting Street-beating first-quarter earnings. Investors were likely reacting to the medtech contract manufacturing giant’s full-year guidance, which was less than the analyst consensus. Plano, Texas–based Integer earned $20.5 million, or 59¢ per share, off of $414.8 million in sales for the quarter ended March 29, 2024. Compared to Q1 […]
Intuitive beats the Street in Q1, increases procedure volume forecast
Intuitive Surgical posted first-quarter results today that exceeded the consensus forecast on Wall Street while increasing its forecast for full-year procedure growth. The Sunnyvale, California-based surgical robotics leader reported profits of $545 million, or $1.51 per diluted share, for the three months ended March 31, 2024, up 53% from the first quarter of 2023. Total […]
IceCure submits final breast cancer cryoablation data to FDA
IceCure Medical (Nasdaq:ICCM) announced today that it submitted final data to the FDA requesting marketing authorization for its ProSense system. Caesarea, Israel-based IceCure designed ProSense to deliver cryoablation that treats breast cancer in a 20-40-minute outpatient procedure. It seeks FDA authorization for treating patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone […]
TSSC seeks funding to get fiber optic sensor tech across the finish line
The Shape Sensing Co. is seeking investors to fund the productization and FDA clearance of its fiber optic sensor technology for surgical navigation. Austin, Texas-based TSSC wants to raise $10 million in the Series B round, CEO Ryan DeBoer said in an interview with MassDevice. That should be enough for two-and-a-half years of runway, enough […]
Medtronic unveils next-gen GI Genius software, partners with ModMed on AI-powered colonoscopy
Medtronic today announced advancements for its AI-powered GI Genius system, as well as a new collaboration. The company unveiled its ColonPRO latest-generation software for the GI Genius intelligent endoscopy system. GI Genius, a computer-aided polyp detection system powered by AI, has been available in the U.S. since 2021. Medtronic designed it to redefine GI screening by […]
Onkos Surgical wins FDA de novo nod for antibacterial-coated orthopedic implants
Onkos Surgical this week announced it received FDA de novo approval for its antibacterial coated implants. According to the Parsippany, N.J.-based company, bacterial contamination of a permanent implant could have devastating effects in orthopedic oncology and revision arthroplasty. “Implant contamination is a growing concern to the orthopaedic surgical community,” Dr. Steven Gitelis, chief medical officer, […]
Orthobond wins FDA de novo approval for antibacterial technology that could have vast device applications
Orthobond has secured FDA de novo approval for its Ostaguard antibacterial technology that could one day be used for a wide range of medical devices — and beyond medtech. The Monmouth Junction, New Jersey-based device developer says it’s the first time the FDA has granted a de novo request for a non-eluting coating designed to […]
Politan picks a new Masimo board fight, targeting CEO’s seat after recent wins
Masimo is fighting with Politan Capital Management again after the activist investor won a heated battle for two seats last year. Politan Managing Partner and Chief Investment Officer Quentin Koffey said his firm is nominating two more candidates for election to the board at this year’s annual meeting in a bid to take control of […]
Masimo looks to separate consumer business two years after $1 billion buyout
Masimo will move forward with a proposal by Chairman and CEO Joe Kiani to separate the medtech developer from its consumer business. Kiani would remain chair and CEO of Irvine, California–based Masimo and serve as chair of the new consumer company, which includes Sound United parent company Viper Holdings that Masimo bought for $1.025 billion […]