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.
Days ahead of its contentious annual shareholders’ meeting slated for Sept. 19, Masimo Corp. established partnerships with two big players – Google LLC and Qualcomm Technologies Inc. – to significantly expand and support the ecosystem for Wear OS smartwatches by developing a next-generation smartwatch reference platform for original equipment manufacturers.
The U.S. FDA approved Apple Inc.’s Airpods Pro 2 as an over-the-counter assistive hearing device for adults with mild-to-moderate hearing loss, making the ubiquitous devices the first assistive hearing technology to receive this designation.
Qure.ai Technologies Private Ltd.’s Qxr artificial intelligence-powered chest X-ray interpretation system identified high-risk pulmonary nodules an average of 32 months before physicians diagnosed lung cancer, a study presented September 8 at the International Association for the Study of Lung Cancer 2024 World Conference on Lung Cancer in San Diego found.
Spectrawave Inc. surfed to a $50 million haul in its series B fundraising round for its Hypervue intravascular imaging system. The company appears to have captured the attention of at least one strategic investor, as Johnson & Johnson Innovation-JJDC Inc. led the round.
Johnson & Johnson subsumed five of its medical technology business under the Johnson & Johnson Medtech name. Ethicon, Depuy Synthes, Biosense Webster, Abiomed and Cerenovus no longer exist as independent entities, but J&J announced no changes in the product lineup.
Femasys Inc. checked off a box on the way to launch of its Fembloc non-surgical birth control method with U.S. FDA clearance of Femchec. An enhanced version of the Femvue product used to diagnose fallopian tube abnormalities, Femchec enables confirmation of successful blockage of the fallopian tubes to prevent pregnancy without use of radiation.
In the first study to compare transcatheter aortic valve replacement or implantation to surgical aortic valve replacement exclusively in women, Edwards Lifescience Corp.’s Sapien 3 and Sapien 3 Ultra valves provided better outcomes.
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.
