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. Read More
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. Read More
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. Read More
The U.S. FTC is taking a bow after Teva Pharmaceutical Industries Ltd. asked the FDA to remove more than 200 patent listings from the agency’s Orange Book.
The opioid crisis may not be front and center anymore, but it’s raging still. A major problem is that overdose-reversal drugs don’t last long enough to help users who opt out of hospital treatment after they are revived. Elysium Therapeutics Inc. CEO Greg Sturmer talks with Randy Osborne about his firm’s candidate for a solution to the medical and societal problem. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Baxter, Caris Life Sciences, Personalis, Volitionrx. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atricure, Biocoat, Bio-Techne, Braincheck, Guardant Health, Illumina, Myome, Ryght AI, Surmodics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Flow Neuroscience, Vesalio. Read More
