Instylla today said it has won FDA 510(k) clearance for its Tembo Embolic System. Bedford, Massachusetts-based Instylla said the Tembo system is a bioresorbable embolization agent with particles designed for embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature. Those irregularly shaped, dry gelatin particles range in size between 85 […]
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Imperative Care wins FDA clearance for Zoom stroke treatment
Imperative Care announced today that it has secured FDA 510(k) clearance for its Zoom comprehensive stroke thrombectomy system. According to Campbell, California–based Imperative Care, the Zoom system is the first such system to include large-bore .088-in. catheters indicated for both access and aspiration when used with one of the company’s Zoom catheters. The FDA clearance […]
Abbott earns Medicare win for CardioMems
An Abbott official said on social media that the company secured a significant Medicare win for its CardioMEMS platform. Keith Boettiger, VP of Abbott’s heart failure business, posted the update on LinkedIn. He said CMS granted a new national coverage determination for CardioMEMS. “This decision is a massive step forward toward increasing access to CardioMEMS […]
Stryker strikes $4.9B deal to buy Inari Medical
Stryker today said it has a definitive agreement to purchase Inari Medical for $80 per share, a big premium that puts the deal’s value at $4.9 billion. Shares of Inari Medical were trading around $48 earlier today. The deal was announced after market close. The deal has been approved by the boards of both Portage, […]
Flow Medical raises seed round for next-gen thrombolysis catheter
Flow Medical has closed a $5 million oversubscribed seed round, the thrombolysis catheter developer announced today. The round includes a previously reported $2 million from friends and family. plus new funding from the University of Chicago Medical Center’s UCM Ventures. “We’re tremendously excited to have the fuel to be able to go after this market, […]
Withings wins FDA clearance for first-of-its-kind blood pressure monitor
Withings Health Solutions announced today that it received FDA clearance for BPM Pro 2, a first-of-its-kind cellular blood pressure monitor. BPM Pro 2 integrates and automates many aspects of clinical workflows. It has FDA clearance to measure blood pressure and pulse rate in adults with arm circumferences of 9-17 inches or 16-20 inches. The company […]
Smith+Nephew layoffs cut beyond Memphis and the ortho business
Former employees at Smith+Nephew (NYSE:SNN) say the device developer’s recent layoffs went beyond what the company has publicly acknowledged. MassDevice was first to report layoffs by Watford, England–based Smith+Nephew to its orthopedics business this month, with the company confirming about 150 job eliminations in Memphis, Tennessee Now, employees in other parts of the U.S. who […]
Capstan Medical raises $110M in Series C round ahead of structural heart robot’s first-in-human procedure
Capstan Medical has raised $110 million in new funding from an oversubscribed Series C round, the structural heart surgical robot developer said today. The funding round was led by Eclipse, with participation from Yu Galaxy and Intuitive Ventures, all three of which had previously invested in Capstan. Joining them in the Series C round is […]
Smith+Nephew announces US layoffs after listing campus for sale
Smith+Nephew (NYSE:SNN) is eliminating jobs in Tennessee, the device developer said in response to an inquiry from MassDevice today. (Update: MassDevice has learned the cuts are deeper than initially reported.) “Smith+Nephew is working to transform to a more efficient, effective and agile business,” a spokesperson said by email. “As we make improvements to our business […]
FDA clears Nonin’s Tru02 over-the-counter fingertip pulse oximeter
Nonin Medical has won FDA 510(k) clearance for its first over-the-counter fingertip pulse oximeter, the TruO2 OTC. The device will be available for purchase on Amazon.com this month, followed by availability through other online retailers. The FDA has warned that pulse oximeters — which beam red and infrared light into a patient’s tissue to measure […]
AdvaMed weighs in on Dr. Oz’s selection to lead CMS
President-elect Donald Trump today said he is nominating Dr. Mehmet Oz to serve as administrator of the Centers for Medicare & Medicaid Services (CMS). Oz would serve under Robert F Kennedy Jr. — who Trump nominated as secretary of the U.S. Department of Health and Human Services — if Oz and Kennedy are confirmed by […]
