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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Flow Neuroscience, Vesalio.
As the systematic dismantling of the U.S. vaccine schedule escalates, the demands to hold Health and Human Services Secretary Robert Kennedy accountable are growing. Claiming that Kennedy has turned his back on science and is endangering public health, Rep. Haley Stevens, D-Mich., formally introduced articles of impeachment against him Dec. 10 for “high crimes and misdemeanors.” Under the Constitution, federal officials can only be impeached for treason, bribery and “other high crimes and misdemeanors.”
Management is beaming with delight at Heartbeam Inc. as the company's appeal strategy paid off with U.S. FDA clearance for its synthetic 12-lead electrocardiogram software for the assessment of arrhythmias. In November, the Santa Clara, Calif.-based company received a Not Substantially Equivalent determination from the agency on its 510(k) application, which could have substantially delayed commercialization. Following a plan disclosed Nov. 28, the company resolved the agency's issues through an appeal process and active engagement and obtained clearance much more quickly than expected.
Alcon AG reported on Dec. 9 that it had sweetened its offer for intraocular lens maker Staar Surgical Co., raising its offer by roughly 10% to $30.75 a share from its prior bid of $28 a share. The revised offer comes on the heels of the expiration of Staar’s go-shop period on Dec. 8, in which Lake Forest, Calif.-based Staar said no superior offers were received.
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