Roche Holdings AG received CE mark approval for the integration of its AI-enabled continuous glucose monitoring system, Accu-Chek Smartguide, with the Mysugr diabetes management app. The integrated solution, which combines predictive CGM technology with therapy data in one place, will simplify the daily decision-making for users managing their diabetes.
China’s National Medical Products Administration is arguably more active than regulatory agencies in many nations in advancing guidance for AI in medical technology, but Chang-Hong Whitney, President/CEO of Whitney Consulting Ltd., told BioWorld that the premarket review process still carries some unpredictability.
After a five-year partnership, Senseonics Holdings Inc. and Ascensia Diabetes Care Holdings AG, a unit of Tokyo-based PHC Holdings Corp., agreed to transition worldwide commercialization and distribution of Senseonics’ Eversense 365 implantable continuous glucose monitor back to Senseonics beginning on Jan. 1, 2026.
Alimetry Ltd. is making waves far beyond its home market with its first-in-class wearable Gastric Alimetry device that measures gut function – an area long considered a black box in gastroenterology.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Elutia, Materna, Immunexpress, Real Heart, Wat Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 23andme, Accustem Sciences, Bioaffinity , Chrome Holding, Carolina Molecular, Cortigent, Emeritus, Exero Medical, Hyperflex, Isto Biologics, Labconnect, Lemonaid Health, Renalytix, SS Innovations, Team Technologies, Tempus AI, Vivani.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amber Impants, Roche.
For enquiring minds that want to know, Susan Monarez laid out the details Sept. 17 of how she was fired as CDC director for the Senate Health, Education, Labor and Pensions Committee.
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