Insulet Corp. received FDA clearance for its Omnipod 5 closed-loop automated insulin delivery (AID) system for patients aged six and older who have type 1 diabetes on Friday, Jan. 28, making it the first tubeless “artificial pancreas” system to get the FDA greenlight. The Omnipod 5 works with Dexcom Inc.’s widely used G6 continuous glucose monitor (CGM) to self-adjust insulin dosing using its Smartadjust algorithm.

Molecular diagnostics could dramatically improve care for one of the most common infections women face, vaginitis. A study by Becton, Dickinson and Co. (BD) found that clinicians miss more than 45% of positive cases and misidentify an additional 12% of negative cases as positives when compared to diagnostic findings.

Patients who received Intersect ENT Inc.’s Propel sinus implant had fewer doctor visits, emergency department and urgent care visits and subsequent endoscopies following surgery for chronic rhinosinusitis, a real-world evidence study found.

Neurometrix Inc. secured breakthrough device designation from the FDA for its Quell technology for chemotherapy-induced peripheral neuropathy (CIPN) just six months after receiving the designation for fibromyalgia in July 2021. Quell is a wearable, credit card-sized transcutaneous electrical nerve stimulation (TENS) device worn on the upper calf that delivers self-adjusting, high-power nerve stimulation that disrupts pain signals sent to the brain.

Medtronic plc received FDA premarket approval Friday for use of its Intellis rechargeable and Vanta recharge-free neurostimulators in patients with diabetic peripheral neuropathy (DPN), suddenly tripling the number of spinal cord stimulators approved for the indication. Medtronic’s implantable spinal cord stimulators (SCS) now join Nevro Corp.’s HFX, which has had the distinction since July 2021 of being the only device with FDA approval for DPN, also known as painful diabetic neuropathy (PDN).

A year after announcing its intention to sell most of the assets of IBM Watson Health, International Business Machines Corp. (IBM) finally reached an agreement with Francisco Partners. Terms of the deal, which is expected to close in the second half of 2022, were not disclosed. The gutting of Watson Health comes less than two months after IBM spun off its $19 billion managed technology services business, Kyndryl Holdings as a standalone company.

With the agreement to purchase Physimax Technologies Ltd. in its rearview mirror, Dariohealth Corp. passes another milestone with its third tuck-in deal in a year. Physimax, a provider of computer vision technology for musculoskeletal (MSK) screening and predictive risk assessment, joins Psyinnovations Inc. (dba Wayforward) and Upright Technologies Ltd. as tuck-ins for the rapidly growing digital health company. The latest deal is by far the smallest. The terms call for the issuance of 256,660 shares of Dariohealth’s common stock, valued at Wednesday’s closing price of $9.65 per share at just under $2.5 million, plus a cash payment of $500,000.

Acutus Medical Inc. provided highlights of a corporate restructuring along with preliminary unaudited revenues for the fourth quarter and year ended Dec. 31, 2021. The company “will prioritize maximizing console utilization and procedure volume growth in targeted geographic regions as well as a more focused scope of product development initiatives.” The restructuring will include the layoff of more than 50 staff members and reduction of manufacturing costs designed to produce annualized operating expense savings of $23 million to $25 million in 2022.

Sema4 Holdings Corp. sent a bold message to the market with a definitive agreement to acquire Genedx Inc. from Opko Health Inc. for $623 million. The deal comes as Sema4 winds down its COVID-19 testing by the end of March. The company has been one of the largest testing organizations in Connecticut since its first contract in May 2020, but has lately come under scrutiny because of an investment by Annie Lamont, the governor’s wife.

With the evidence that sex and gender both significantly affect the course of many diseases and the function of medical devices rapidly mounting, the FDA’s Center for Devices and Radiological Health (CDRH) released its strategic plan to better understand these differences.