The FDA announced that ResMed’s voluntary recall of millions of CPAP mask magnets is now Class I, the agency’s most serious level. Last month, ResMed warned CPAP users about potential magnetic interference when magnets go near certain implants and medical devices in the body. People using CPAP masks with magnets only need to return […]
News Well
FDA clears painful diabetic neuropathy neurostim therapy from Neuralace
Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy […]
The biggest stories from the 2024 J.P. Morgan Healthcare Conference
Some of the biggest names in medtech came together this week at the J.P. Morgan Healthcare Conference. They shared updates on financial progress, operational changes and new products, among other things. Medtronic shared details on plans to restore earnings power, while Abbott highlighted the success of its FreeStyle Libre system. Shockwave Medical outlined its plans […]
Study backs Smith+Nephew Regeneten bioinductive rotator cuff implant
Smith+Nephew today announced positive results for its Regeneten bioinductive implant from a randomized controlled trial. Data published online in Arthroscopy highlighted the success of Regeneten against the standard of care. One-year results found that medium and large full-thickness rotator cuff tears repaired and augmented with the implant had better tendon healing. Regeneten provides a patient-centric […]
Nevro announces layoffs
Pain-treatment device company Nevro (NYSE:NVRO) announced that it is letting go of 63 employees, about 5% of its workforce, as part of a restructuring effort. “This restructuring supports our strategy and allows us to focus our investments to further position Nevro for long-term growth and profitability,” Nevro CEO Kevin Thornal said in a news release […]
Shockwave Medical plans for growth with 2-3 product launches each year
It was a busy 2023 for Shockwave Medical (Nasdaq:SWAV), with product launches, funding rounds and M&A at the heart of it. The company, which develops intravascular lithotripsy (IVL) technology, first made waves last year with its acquisition of Neovasc. Neovasc develops the Reducer system for addressing refractory angina. Shockwave remained in the middle of M&A […]
3M wins $34.2M contract to develop wound care solutions
3M Health Care announced that its Medical Solutions Division received a $34.2 million award from the U.S. Army Medical Research Acquisition Activity. The award enables 3M to develop a range of new solutions for infection prevention, wound management and wound healing. St. Paul, Minnesota-based 3M plans to lead a program focused on treatment strategies for […]
First arthroplasty procedures performed with Stryker mixed-reality guidance system
Stryker announced today that surgeons completed the first shoulder arthroplasty surgeries using its mixed reality (MR) guidance. Dr. Joaquin Sanchez-Sotelo of Mayo Clinic and Dr. George Athwall of St. Joseph’s Health Care (London, Canada) performed the surgeries. Kalamazoo, Michigan–based Stryker designed its Blueprint MR guidance system to combine software with the Microsoft HoloLens 2 headset. […]
Dexcom submits new glucose sensor to FDA, expects launch this summer
Dexcom announced that it submitted its new Stelo glucose sensor to the FDA for review at the end of last year. The continuous glucose monitor (CGM) maker designed Stelo specifically for people with type 2 diabetes who do not use insulin. San Diego-based Dexcom designed Stelo for a 15-day wear with a cash-pay option. It […]
Embecta submits insulin patch pump for FDA clearance
Embecta (Nasdaq:EMBC) announced today that it submitted a 510(k) premarket filing to the FDA for its proprietary insulin patch pump. The Parsippany, New Jersey-based BD Diabetes spinoff developed a proprietary, disposable pump for people with type 2 diabetes. The company provided analysts with some details on the makeup of the open-loop system earlier this year. It […]
iRhythm releases strong Q4 prelims, strengthens balance sheet
iRhythm Technologies today released a solid preliminary earnings update that included projections of up to 20% revenue growth in 2024. The wearable cardiac monitors developer saw IRTC shares jump more than 7% in value to $112.91 apiece by the close of trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical […]