The U.S. FDA’s approval of the Abbott Laboratories Triclip was predicated on a data set comprised of 350 patients, but an additional bolus of data seems to reinforce the rationale for the FDA approval, including improvements in quality of life.
Remote monitoring for patients with implanted cardiac electrophysiology devices may finally be coming of age in the U.K. thanks to a review of these systems by the National Institute for Health and Care Excellence.
Abbott Laboratories reported it achieved new major milestones to support the company's growing suite of pulsed field ablation (PFA) solutions in electrophysiology: early completion of enrollment in the VOLT-AF IDE study supporting the Volt PFA system, and the launch of the Focalflex trial to assess the company's Tactiflex Duo ablation catheter, sensor enabled, which will be used in the treatment of patients with paroxysmal atrial fibrillation.
Noul Co. Ltd.’s Micro-Intelligent Laboratory, an artificial intelligence-powered diagnostic system, demonstrated superiority over microscopic diagnosis for malaria in a study presented at the 2024 International Congress for Tropical Medicine and Malaria.
The U.S. FDA cleared Senseonic Holdings Inc.’s Eversense 365, the first continuous glucose monitor to last a full year with a single sensor rather than the 10 days to two weeks typical for wearable sensors such as those offered by Abbott Laboratories and Dexcom Inc.
Abbott Laboratories’ diabetes unit opened the month with a two-cannon salvo – a partnership with Beta Bionics Inc. that will integrate Abbott’s Freestyle Libre 3 Plus continuous glucose monitor with the Ilet Bionic Pancreas system and the roll out of its over-the-counter Lingo CGM in the U.S.
Hope for definitive resolution of the controversy about the superiority of transcatheter edge-to-edge repair of mitral valves over medical therapy in individuals with symptomatic heart failure and functional mitral regurgitation were dashed at the European Society of Cardiology meeting this weekend.
As of this week, consumers can order Dexcom Inc.’s Stelo continuous glucose monitor (CGM) online without a prescription, making it the first to hit the market. Dexcom will have competition soon, however, with Abbott Laboratories planning to roll out its over-the-counter Lingo and Libre Rio CGMs in short order.
A magistrate judge for a U.S. district court has recommend that Abbott Laboratories receive $54 million in damages for third-party diversion of glucose test strips into the U.S. from other nations.
Insulet Corp.’s Omnipod 5 automated insulin delivery system has been cleared by the US FDA for the indication of type 2 diabetes, making it the first automated insulin delivery system cleared for both type 1 and type 2 diabetes management.