Medtronic plc made history with the first U.S. FDA approval of pulsed field ablation for paroxysmal and persistent atrial fibrillation in the U.S., giving the company a significant first-mover advantage in a field that is expected to cannibalize the cardiac ablation market. Read More
The U.S. FDA’s draft guidance for selection of a predicate device in 510(k) submissions is part of a larger effort to overhaul the 510(k) program, but industry’s response is that this draft guidance goes too far. Read More
South Korean artificial intelligence software developer Lunit Inc. plans to acquire Volpara Health Technologies Ltd. for $193 million (AUD 292 million) by mid-2024, taking a global leap to the U.S. market and becoming an AI-based platform health care firm. Read More
Carthera SA received an additional €4.5 million (US$4.9 million) from investors to take its series B funding round to €42 million despite a tough fundraising environment for med-tech companies. Frédéric Sottilini, CEO of Carthera, told BioWorld that the strong investor interest was testament to their confidence in the company’s Sonocloud technology for brain disorder treatment. Read More
Sound Wave Innovation Co. Ltd. seeks patent protection for a method of using an ultrasonic device which transmits non-converging ultrasonic energy to the brain for the treatment of dementia, including mild Alzheimer’s-type dementia and mild cognitive impairment. Read More
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Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alveo, Anheart, Arteraai, Bactiguard, BD, Biostem, Coreplus, Delfi Diagnostics, Exopert, Foundation One, Fresenius, Haystack Oncology, Imperative Care, Invitae, Ossium, Quest, Trisalus. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bonesupport, Corista, Glaukos, Medtronic. Read More
