Medtronic plc got a jump on its cardiology competitors with big news ahead of the Transcatheter Cardiovascular Therapeutics (TCT) conference that starts on Oct 24 in San Francisco, with U.S. FDA approval of its Aurora extravascular implantable cardioverter-defibrillator (EV-ICD). The system delivers defibrillation and heart pacing without placing wires in the heart or vasculature. That puts it in direct competition with Boston Scientific Corp.’s Emblem S-ICD, currently the only player in the market. Read More

Seastar Medical Holding Corp. was granted a third breakthrough device designation by the U.S. FDA for its Selective Cytopheretic device (SCD), a biomimetic membrane-based device used to treat patients with acute inflammatory conditions, which can cause organ failure and death. The latest designation is for its use in patients with hepatorenal syndrome. It follows other indications including cardiorenal syndrome and in adults with acute kidney injury (AKI). Read More

With an eye on increasing U.S. competitiveness and expanding the opportunities of technology hubs beyond those already established on the country’s two coasts, the Biden administration designated 31 communities, out of more than 370 applicants, as Regional Innovation and Technology Hubs. Read More

Researchers may have figured out how to cut the hypertension that poses the most common threat in pregnancy. Read More

The U.S. FDA is once again revising its guidance on how drug and device makers can share scientific reprints and reference texts with health care providers regarding off-label uses of their approved or cleared products. Read More

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The top 10 med-tech stock gainers and losers for the week. Read More

New hires and promotions in the med-tech industry, including: Neuros. Read More

Med-tech firms raising money in public or private financings, including: Aurora. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Exact Sciences, Guardant Health, Oncohost. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Elekta, Icad, Invo Bioscience, Naya Biosciences. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insulet, Huizhou Jinghao, Ludica Medical, Medtronic, Vuno. Read More