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.
Nia Therapeutics Inc. reported data from an in vivo study of its Smart Neurostimulation System, an AI-based brain-computer interface (BCI), which demonstrated its ability to perform chronic sensing, neural-state decoding and programmable stimulation.
The U.K. National Institute for Health and Care Excellence posted a draft update on its recommendations for ovarian cancer testing, proposing several changes that may lead to earlier intervention in the ovarian cancer disease cycle.
Australia’s Therapeutic Goods Administration posted a proposed rework of the agency’s conformity assessment procedures that would align with EU regulations, but the agency stated clearly that it is aware of some of the hazards of further alignment with the troubled European regulations.
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