Reports of the death of the market for continuous glucose monitors in individuals with type 2 diabetes are greatly exaggerated, Abbott Laboratories studies show. Far from being unnecessary given the enthusiastic uptake of GLP-1 drugs, the devices significantly improve blood glucose control regardless of the drug used, duration of SLP-1 therapy or use of insulin, presentations at the International Conference on Advanced Technologies & Treatments for Diabetes in Florence, Italy, demonstrated.
In a grand slam for Dexcom Inc., the U.S. FDA cleared its Stelo glucose biosensor system for over-the-counter marketing, making it the first integrated continuous glucose monitor available without a prescription. Designed for use by the 25 million adults with diabetes who do not use insulin and do not have problematic hypoglycemia, the FDA indication expanded the clearance for Stelo to include individuals without diabetes “who want to better understand how diet and exercise may impact blood sugar levels,” dramatically expanding the market opportunity.
Osang Healthcare Co. Ltd. is attempting a second listing on the Kosdaq market with an IPO, planned sometime in March, to fund the company’s growth beyond the COVID-19 pandemic.
Insulet Corp. received the greenlight from EU regulators to combine its Omnipod 5 automated insulin delivery (AID) system with Abbott Laboratories Freestyle Libre 2 Plus sensor to treat individuals aged two years and older with type 1 diabetes.
Kakao Healthcare Corp. launched an artificial intelligence (AI)-powered mobile application called PASTA on Feb. 1 for continuous glucose monitoring (CGM)-based diabetes care. PASTA pairs with two types of CGM sensors, either from Seoul-based I-sens Inc.’s Caresens Air or San Diego-based Dexcom Inc.’s G7 system.
Trinity Biotech plc. paid $12.5 million to acquire Waveform Technologies Inc.’s biosensor and continuous glucose monitoring (CGM) assets. It also formed a partnership with Bayer AG to launch a CGM biosensor in China and India. These moves are part of Trinity’s transformation strategy to become a leading player in wearable biosensor technology.
The U.S. Patent and Trademark Office’s inter partes review mechanism has drawn uneven reviews in the past decade or so and Dexcom Inc. has serious misgivings about an attempt by Abbott Diabetes Care Inc. to use the process to invalidate Dexcom patents for continuous glucose monitors.
Medtronic plc received CE mark for its latest miniature, leadless pacemakers, the Micra AV2 and Micra VR2. According to the company, they are the world's smallest pacemakers, provide a longer battery life, and are easier to program than previous Micra pacemakers, while maintaining the benefits of their predecessors such as reduced complications compared to traditional pacemakers.
Dexcom Inc. achieved the first integrations of an automated insulin delivery system (AID) approved for use in the U.S. with its G7 continuous glucose monitoring (CGM) integrating with Tandem Diabetes Care Inc.’s T2:slim X2, announced on Dec. 6, and integration with the Ilet Bionic Pancreas made by Beta Bionics Inc. revealed on Dec. 7.
One of the largest med-tech deals of 2023 was wiped off the charts when Medtronic plc terminated a $738 million agreement to acquire South Korean wearable insulin patch maker Eoflow Co. Ltd., citing “multiple breaches” under its agreements, on Dec. 6.
