Outset Medical (NSDQ:OM) announced that it closed a previously announced underwritten public offering with proceeds of approximately $149.7 million. San Jose, Calif.–based Outset offered 2.9 million shares of common stock sold by the company itself, plus nearly 3.9 million shares of its common stock sold by certain stockholders at a public offering price of $53.50 per […]
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Could BrainCheck’s simple test help COVID long-haulers?
BrainCheck’s eponymous mobile neurocognitive test can detect dementia and concussion. But it has a new application: post-COVID brain fog. Developed by neurologists at Baylor College of Medicine’s Eagleman Laboratory for Perception and Action, BrainCheck carries an FDA Class II Software as a Medical Device (SaMD) designation and can be used on a tablet or laptop in […]
Feds halt J&J COVID-19 vaccine due to blood clot concern
The FDA and CDC issued a joint statement today recommending the pause in the administration of the Johnson & Johnson COVID-19 vaccine. As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood […]
BioCorp, Roche launch Mallya smart insulin pen in France
BioCorp and Roche Diabetes Care France announced the launch of the Mallya smart insulin pen device in France. Developed by BioCorp, Mallya is an intelligent sensor for insulin injection pens that has CE mark approval in Europe. The platform is compatible with any disposable insulin pen. It enables reliable monitoring for doses selected for injection and it offers […]
Medical device companies put $3.6 billion in docs’ pockets, study finds
Medtech companies paid $3.62 billion for access to physicians — 10% more than drug companies did — from 2014 to 2017, according to new research. Device company payments to surgical specialists were significantly more tied to the surgeons’ Medicare billing than payments from drug companies to specialists, according to the study, which appears in the April 2021 […]
DiaSorin to buy Luminex for $1.8B
DiaSorin announced that it agreed to acquire Luminex in an all-cash transaction worth approximately $1.8 billion. Saluggia, Italy-based DiaSorin’s purchase at $37 per share of Luminex represents a 23.1% premium to Luminex shareholders based on the unaffected closing stock price of the company on Feb. 24, 2021, which was the date prior to press rumors […]
Microsoft spending $19.7B on Nuance and its AI for healthcare providers
Microsoft announced today that it will acquire Nuance Communications and its AI-based software used by healthcare providers. Under the agreement, Microsoft will buy Nuance at $56 per share, representing a 23% premium to Nuance’s closing price on Friday, April 9, 2021. The all-cash transaction is valued at $19.7 billion, inclusive of Nuance’s debt, according to […]
Memic raises $96M to support surgical robot with humanoid-shaped arm
Memic Innovative Surgery announced today that it closed a $96 million Series D financing round. Tel Aviv, Israel-based Memic develops Hominis, the first FDA-approved robotically-assisted surgical device for performing transvaginal hysterectomy, with indication for performing benign hysterectomy with salpingo-oophorectomy. The FDA approved the Hominis system last month. Hominis is designed to remove the uterus using […]
Zoll Medical acquires Respicardia
Zoll Medical said today that it has acquired Respicardia and its neurostimulation tech for treating sleep apnea. The financial terms of the deal were not disclosed. Respicardia makes implantable neurostimulators to treat moderate to severe central sleep apnea (CSA). The system is FDA approved to treat severe CSA in adult patients with reduced cardiac function. […]
Medtronic has a serious recall of ICDs and CRT-Ds
FDA has issued a Class I designation of a Medtronic (NYSE: MDT) recall involving 239,171 ICDs and CRT-Ds with potential battery life problems. The agency reported 444 complaints regarding the devices: Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-Ds) distributed from Aug. 31, 2012, to May […]
Lyra Therapeutics touts results from chronic rhinosinusitis treatment trial
Lyra Therapeutics (NSDQ:LYRA) presented positive results from a Phase 2 study of its therapeutic for treating chronic rhinosinusitis (CRS). Watertown, Mass.-based Lyra’s Phase 2 Lantern study evaluated its LYR-210 long-acting product for CRS, which is administered in-office to deliver a sustained release for up to six months as a non-invasive alternative to surgery for patients who […]