Software as a service has typically been less susceptible to liability than products, but that may soon come to an end if the AI LEAD Act, sponsored by a bipartisan pair of members of the Senate, gains sufficient traction.
China’s National Medical Products Administration (NMPA) has issued guidance governing online sales of medical devices with a focus on inspections of the products’ manufacturing facilities. The agency made it clear that the manufacturer will have to deal promptly with any deviations from the regulations or face enforcement action, signaling a new era of tighter scrutiny of online sales of these products.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cumulus Neuroscience, Freenome Holdings, Hyperfine, Linus Health, Ventric Health.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Gore, Spectrumedics, Stereotaxis.
Over the last year, diabetes technology saw significant changes, including the acceleration of patch pumps, ever-smaller continuous glucose monitors (CGM), implanted CGMs and increased interest in devices that measure additional chemicals in blood without needles.
Sustaining healthy weight loss is about much more than cutting calories or injecting drugs, as many glucagon-like peptide-1 (GLP-1) receptor agonist users are discovering. Widely seen as miracle drugs, semaglutide, tirzepatide and related medications have transformed the treatment of obesity and diabetes and apparently lessened the need for medical device intervention in many instances. However, many patients will still need surgical intervention to achieve their weight loss goals.
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