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.

Shenzhen Chipscreen Biosciences Co. Ltd.’s Bilessglu (chiglitazar), a peroxisome proliferator-activated receptor (PPAR) pan-agonist globally for the treatment of type 2 diabetes mellitus, has received marketing approval from the NMPA in China.

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.

Merck KGaA has signed an agreement with French company Biocorp SA to develop a version of its Mallya smart device for monitoring human growth hormone (HGH) treatment. Mallya is a clip-on device for pen injectors that collects the dose and time of each injection and transfers the information in real time to a companion software using Bluetooth technology. The device is CE marked (Class IIb) and was first launched in France in 2020.

The Tokyo University of Science (TUS) has developed a self-powered diaper biosensor that can monitor urine sugar levels, which could be a boon for both diabetic patients and their caregivers. Caregivers at nursing homes currently open patients’ diapers every few hours to check for urination, thus increasing the caregivers’ workload. The psychological impact on the patient is also increased, for example when their sleep is disturbed.

Rokit Healthcare Inc. received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for Dfurege, its artificial organ platform to treat diabetic foot ulcers. “We hope that having a South Korean approval for this platform will be a boost for our planned IPO,” Seok Hwan You, CEO at Rokit, told BioWorld.