Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cadwell Industries, Datasea, Essilorluxottica Mainstay Medical, Sentante.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Peijia Medical, Ruthless Spine, Zenflow.
Investigators at the Netherlands Hubrecht Institute have developed a novel gut organoid model, and used it to gain insight into the functions on human microfold (M) cells. Their experiments, which were published in the Dec. 10, 2025, issue of Nature, showed that M cells present gluten-derived antigens to T cells, which suggests a role for this cell type in the onset of celiac disease.
Restricting the recommended use of COVID-19 vaccines in the U.S. wasn’t enough. Now the Children’s Health Defense (CHD) is trying to get the FDA to revoke the BLAs for all versions of the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines.
Flow Neuroscience AB received U.S. FDA 510(k) approval for its Flow at-home brain-stimulation device to treat major depressive disorder. The wearable headset uses mild electrical current to stimulate specific areas of the brain to reduce depressive symptoms in as little as three weeks.
The first international consensus framework for the use of continuous ketone monitoring in people with diabetes, published in The Lancet Diabetes & Endocrinology, calls development and use of ketone sensors for the prevention of diabetic ketoacidosis “transformational.” Several companies in the diabetes technology market have recently reported that they are developing dual glucose-ketone sensors, though none have gained U.S. FDA approval yet.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Baxter, Caris Life Sciences, Personalis, Volitionrx.
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