The U.S. CMS has crafted a payment policy that covers both adjunctive and non-adjunctive continuous glucose monitors (CGMs) in the final rule for durable medical equipment (DME). Medtronic plc, of Dublin, heralded the move as “a very important benefit expansion” for the company’s customers, but the expanded coverage also pays for additional CGMs that work with Medtronic insulin pumps.

Diabetes care will continue to evolve in 2022. New digital offerings and advanced algorithms, along with new product launches in insulin pumps and continuous glucose monitoring (CGM) will power growth in the future, according to key analysts. While many medical device sectors have suffered during the COVID-19 pandemic, diabetes care has continued to grow.

Vicentra BV has closed a $74 million series C financing round to accelerate the European rollout of its wearable insulin patch. The small, lightweight system Kaleido is the company’s flagship product and consists of two pumps controlled by a Bluetooth wireless connected handset. The small size rests on a pumping action that – unlike a conventional syringe mechanism – uses micro-pulse technology to deliver accurate and consistent doses of insulin.

Glyconics Ltd. landed £1.5 million (US$2 million) in an Enterprise Investment Scheme funding round to finance a clinical trial of its diabetes screening tool, Glyconics-SX. The Cambridge, U.K.-based diagnostics company is developing a point-of-care, hand-held device using miniaturized infrared (IR) spectrometry. The technology scans fingernails, assessing glycation to identify diabetes within minutes.

Investors have injected $8.4 million into Swedish startup Sigrid Therapeutics AB to speed development of its oral medical device Sipore15. The technology is a tasteless and odorless white powder taken with water to reduce blood sugar levels in people at risk of developing diabetes.

Despite the morbidity associated with coronary artery bypass graft, this procedure has never been entirely displaced by percutaneous coronary intervention. The results from the latest in a series of studies does not seem to help the case for drug-eluting stents (DES) for patients with three-vessel disease, as the data from this study failed to demonstrate non-inferiority for DES devices implanted with the help of fractional flow reserve measurement to ensure optimal stent placement.

Microtech Medical (Hangzhou) Co. Ltd. raised around HK$1.98 billion (US$254.53 million) via its listing on the Hong Kong stock exchange, becoming the latest in a flood of med-tech companies listing in the city.

The FDA reported two class I recalls associated with insulin pumps made by Dublin-based Medtronic plc, albeit for two significantly different issues. The two recalls affect roughly 495,000 units combined, and may significantly affect access to some patients. One of the recalls was for Minimed 600 series insulin pumps, a recall announced in 2019 and expanded in October. The recall addresses the risk of incorrect dosing of insulin due to a faulty clear retainer ring, which is used to lock the insulin cartridge into place in the insulin pump reservoir. The second recall is for remote controllers used with Medtronic insulin pumps. In this instance, the action was undertaken due to cybersecurity concerns, although the controllers in question are no longer in distribution.

Glucomodicum Oy tapped contract manufacturer Phillips-Medisize LLC to develop its needle-free continuous glucose monitor (CGM), Talisman, which is based on Glucomodicum’s magnetohydrodynamic (MHD) platform technology that measures glucose levels from interstitial fluid. The wearable CGM – the size of a smartwatch – combines MHD technology with biosensors and algorithms so health care professionals can monitor patients’ diabetes.

Once upon a time, Intarcia Therapeutics Inc. was a biotech unicorn valued at $3.5 billion. Its allure was its implantable Medici drug delivery system that consisted of a mini pump about the size of a matchstick. But a unicorn’s life is never completely charmed. Intarcia faced obstacles along the way – two complete response letters from the U.S. FDA and the denials of three formal dispute resolution requests. Now it looks like this story won’t have a happy ending.