At long last, the FDA granted premarket approval to Senseonics Holdings Inc.’s fully implantable Eversense E3 continuous glucose monitoring (CGM), an implantable device that provides accurate glucose readings for six months. The CGM will be available in the U.S. through Senseonics’ commercial partner, Ascensia Diabetes Care Holdings AG, starting in the second quarter. In Europe, the previous generation Eversense XL is available today and the company plans to launch the E3 in the third quarter of 2022.

As attention turns to new drugs that can address the growing burden of Alzheimer’s disease (AD) in an aging global population, Retispec Inc. has developed a noninvasive test that may be able to detect early signs of the neurodegenerative disease decades before clinical symptoms appear – and when therapies appear to be most helpful in slowing or reversing Alzheimer’s. By using “off-the-shelf” ophthalmic equipment, the Toronto-based company’s solution enables assessment by optometrists or other eye professionals during a standard eye exam.

Bioventrix Inc. acquired Materacor Inc., the developer of a heart failure therapy that uses an injectable alginate-based hydrogel and a minimally invasive endocardial delivery system to restructure the left ventricle and reverse or stop the progression of ischemic or non-ischemic congestive heart failure with reduced ejection faction (HFrEF). The terms of the transaction were not disclosed.

The Cooper Companies Inc. plans to acquire the entirety of Cook Medical Inc.’s reproductive health business in this fiscal quarter for $675 million at closing plus $200 million paid in four $50 million annual installments. The acquisition will expand Cooper’s presence in the Asia-Pacific region. The Cook deal will also accelerate Cooper’s labor and delivery medical device efforts by adding 115 people sales, marketing, education and support staff globally.

Combining Sarepta Therapeutics Inc.’s gene editing technology and Genedit Inc.’s Nanogalaxy platform to treat neuromuscular disorders shows promising potential, the companies reported. A year into the research collaboration, Genedit’s polymer nanoparticles have demonstrated the ability to deliver therapeutic cargo to specific muscle tissue following system administration of targeted genetic medicines.

Biocardia Inc. received FDA breakthrough device designation for its Cardiamp cell therapy system for treatment of heart failure. The good news provided a welcome 27% boost to the share price (NASDAQ:BCDA), lifting it from $1.57 at Wednesday’s close to $2.00 by the market’s close Thursday. Extended timelines for trials associated with the pandemic have hammered the company, which has seen its stock price fall more than 60% in the last two years.

Based on the BCG Digital Ventures-Boston Consulting Group’s just issued 2022 Future of Digital Health: Health Care Innovation Predictions, the group expects 2022 to continue the trends seen over the last two years. Focus on “care anywhere” will support a continued increase in telemedicine use and, with it, advances in home-based testing, diagnostics and monitoring devices.

Glooko Inc. acquired Xbird GmbH to further build out its diabetes management platform by adding Xbird’s just-in-time artificial intelligence (JITAI) system to provide adaptive interventions that can enable better informed decision making in the moment. The company declined to provide details of the transaction.

With the rates of nonalcoholic steatohepatitis (NASH) rapidly rising, Glympse Bio Inc. and Laboratory Corp. of America Holdings Inc. (Labcorp) have announced new tests that can assess the risk of the liver condition without the traditional biopsy.

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.