Dexcom Inc. and Insulet Corp. both reported introductions of their products into new countries on the eve of the 2024 American Diabetes Association annual meeting in Orlando, Fla. The two firms also announced the U.S. launch of Insulet’s Omnipod 5 tubeless automated insulin delivery system with connectivity to Dexcom’s G7, the company’s latest generation continuous glucose monitor.
Hagar Non-invasive Glucose Monitoring Ltd.’s non-invasive radiofrequency (RF) glucose monitor, Gwave, demonstrated high concordance with both venous and capillary glucose measurements in a study published in Diabetes Technology & Therapeutics.
Abbott Laboratories received U.S. FDA clearance for its Lingo and Libre Rio over-the-counter continuous glucose monitoring systems, enabling it to challenge Dexcom Inc. in this rapidly growing market. Dexcom received FDA clearance for its OTC Stela continuous glucose monitor in March.
In a sweet indication of an improving capital market for med-tech companies, Biolinq Inc. landed $58 million in bridge financing to support completion of the U.S. pivotal trial of its intradermal glucose sensor and submission to the U.S. FDA. The round brings the total raised to more than $170 million. With good response so far, the company is optimistic that it can attract more funding in short order. “Biolinq also plans to raise a series C financing of more than $100 million to support commercialization at the end of this year,” Biolinq CEO Rich Yang told BioWorld.
Medical device company Know Labs Inc. reported results from a new study showing that continued algorithm refinement combined with more high-quality data significantly increased the accuracy of its Body-Radio Frequency Identification, or Bio-RFID, sensor technology to measure and detect changes in blood glucose levels.
The recently concluded American Diabetes Association’s (ADA) 83rd Scientific Sessions continued to build powerful use cases for continuous glucose monitors in an ever-wider population and to highlight the value of automated insulin delivery (AID) systems that are getting ever-closer to duplicating the function of a natural pancreas. In addition to the news from Medtronic plc and Dexcom Inc. BioWorld covered earlier this week, Abbott Laboratories, Tandem Diabetes Care Inc. and Insulet Corp. also presented bright projections for future performance.
At the American Diabetes Association (ADA) Annual Meeting this weekend, Medtronic plc provided an update for investors and showcased results from its devices that all demonstrated better time in range for users. The Dublin-based company provided strong results with the U.S. FDA warning letter now behind it and the 780G Minimed pump and Guardian 4 sensor launches well underway.
Dexcom Inc. rolled out its plans for 2024 and 2025 at an Investor Day event held at the beginning of the American Diabetes Association Annual Meeting in its hometown of San Diego on June 23. The company is looking to expand from diabetes into metabolic health more broadly and previewed several new products designed to appeal to a wider market.
Three months earlier than anticipated, CMS published its final local coverage determination (LCD) for continuous glucose monitors and included more people with diabetes than expected. The new policy expands coverage from individuals with type 1 diabetes or type 2 diabetes using multiple daily injections of insulin to anyone treated with insulin, essentially doubling the market for manufacturers of continuous glucose monitors (CGMs).
Insulet Corp. reported much better than expected fourth quarter results, following on Dexcom Inc.’s report of earlier than expected coverage decision from CMS for its just-approved G7 continuous glucose monitor. Insulet (NASDAQ:PODD) soundly beat Wall Street’s expectations for quarterly revenue by $38 million, bringing in $332 million instead of the anticipated $332 million, driven by strong uptake of its Omnipod tubeless insulin pump.