The first day of the U.S. FDA’s two-day advisory hearing on generative artificial intelligence reflected some of the anxieties attached to this emerging technology, with the phenomenon of hallucinations driving several calls for more stringent regulation of this class of products that might be applied toward other entries in the class of artificial intelligence.
Edwards Lifesciences Corp. revealed excellent one-year data highlighting the performance of its newest generation Sapien 3 Ultra Resilia valve. Patients treated with the transcatheter aortic valve replacement system experienced lower rates of mortality and reintervention compared to its predecessors.
On the heels of U.S. FDA approval for Neurophet Aqua, an updated version of its artificial intelligence (AI)-based magnetic resonance imaging analysis software for the brain, Neurophet Inc. is preparing for an IPO in 2025 and expansion into U.S. and European markets.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Boston Scientific, Briohealth Solutions, Illumina, Intera Oncology, Insulet, Myriad Genetics, RTI Surgical, Virtual Incision.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lifesignals, Medtronic, Stereotaxis, Microport.
Former U.S. FDA Commissioner Margaret Hamburg has added her voice to concerns that the incoming Trump administration’s pledge to slim down federal agencies will damage public health. “These are certainly challenging times,” Hamburg told delegates at the World Science Forum, Budapest, Hungary, meeting to discuss issues dominating the interface between science and policy.
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