BD (NYSE:BDX) announced today that it will build a more than $200 million drug delivery device manufacturing facility in Spain. The approximately $201.5 million (€165 million) high-tech manufacturing facility in Zaragoza, Spain, is expected to create up to 600 jobs by 2030, according to a news release. Get the full story at our sister site, Drug […]
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5 of the latest cardiac tech insights out of ACC.21
The American College of Cardiology’s 70th Annual Scientific Session has produced some positive news about some controversial cardiac tech. Drug-coated stents, which a 2018 study linked to late-stage death, were shown to be non-inferior to non-drug-coated stents in patients with peripheral arterial disease. And a new study of renal denervation that used a different methodology […]
50 of 2020’s best-selling pharmaceuticals
Drug sales in 2020 proved more resilient than many experts anticipated in the early days of the pandemic. Still, the impact on many injectable drugs was tangible in the first half of the year as hospitals initially dissuaded patients from seeking in-person treatment. But sales were generally strong for the full year. AbbVie’s injectable biologic […]
ReCor Medical has positive renal denervation study news
ReCor Medical‘s renal denervation significantly reduced blood pressure among people with drug-resistant hypertension, according to a new study reported at the American College of Cardiology’s 70th Annual Scientific Session. The study news, announced yesterday, could suggest a turnaround in fortunes for renal denervation technology. One considered the next big thing in the medical device industry, […]
Abbott wins CE mark for Navitor TAVI
Abbott (NYSE:ABT) announced today that it received CE mark approval for its Navitor transcatheter aortic valve implantation (TAVI) system. The latest-generation TAVI system from Abbott, Navitor won European approval for treating those with severe aortic stenosis who are at high or extreme surgical risk, according to a news release. Navitor uses Abbott’s FlexNav delivery system […]
CMS delays Medicare payments for breakthrough devices until December
Medicare coverage for FDA-designated breakthrough medical devices will have to wait several more months, despite broad support. The Centers for Medicare and Medicaid Services (CMS) issued a final rule on Medicare Coverage of Innovative Technology (MCIT) in January, granting coverage for breakthrough devices the same day as their FDA approvals, for up to four years. Immediately […]
DTW Podcast: Getting to the heart of Boston Scientific’s peripheral business; How Hologic sees trials changing
In this week’s episode of the DeviceTalks Weekly Podcast, Boston Scientific peripheral business EVP Jeff Mirviss explains why the specialty’s name doesn’t really reflect the importance of arteries, veins and other critical “highways” in the body. Mirviss explains where the peripheral business is headed, and why Boston Scientific is uniquely positioned to address the business. […]
This imaging device could be a breast cancer treatment breakthrough
OncoRes Medical’s system may detect cancer cells on a microscopic scale during a lumpectomy, potentially averting the need for a second breast cancer surgery. Having breast surgery to remove a cancerous lump is traumatic enough. Learning that you’ll need another operation to remove cancer cells that the surgeon couldn’t detect the first time only adds […]
Axonics closes $201.3M offering
Axonics (NSDQ:AXNX) announced today that it closed a public offering of common stock worth proceeds of more than $200 million. Irvine, Calif.-based Axonics, which develops the Axonics r-SNM (sacral neuromodulation) system to treat bladder and bowel dysfunction, offered more than 4 million shares of its common stock at $50 per share, according to a news […]
Cue Health raises $235M to support its over-the-counter, home-use diagnostics
Healthcare technology company Cue Health announced that it closed a private financing round worth $235 million. Existing investors Johnson & Johnson Innovation — JJDC, Decheng Capital, CAVU Ventures, ACME Capital and more contributed to the financing, as did new investors Perceptive Advisors, MSD Capital and Koch Strategic Platforms, according to a news release. Morgan Stanley […]
FDA warns about consumer electronics and implanted devices
The FDA is advising the public that certain consumer devices have high-field strength-magnets that can send medical devices into “magnet mode.” Magnets of this nature can affect the normal operations of implanted medical devices until the magnetic field is moved, according to the FDA news release. Get the full story at our sister site, Medical […]