Three years after the U.S. FDA approval of Abbott Laboratories’ Amplatzer Amulet, results of its investigational device exemption trial failed to notably differentiate Abbott’s left atrial appendage occluder system from Boston Scientific Corp.’s market-dominant Watchman device beyond the ability to forego anticoagulants quickly after implantation.

Boston Scientific Corp.’s OPTION study demonstrated left atrial appendage closure with the Watchman Flx device reduced risk of stroke compared to management with direct oral anticoagulants or warfarin in patients with atrial fibrillation following cardiac ablation. Results were presented at the American Heart Association's Scientific Sessions 2024 and simultaneously published in The New England Journal of Medicine.

While women’s health has slid under the research radar for decades, large biopharma companies and venture capital firms are beginning to take notice of the untapped market potential. More companies are wandering into the space and exploring avenues of science that were largely ignored for years. A BioWorld analysis of biopharma companies working on women’s health solutions found that while many efforts to improve the well-being of women exist, the proportion of funding and partnering for this emerging sector of medicine still represents only a small slice of the industry’s overall activity.

Boston Scientific Corp. resumed enrollment in the AVANT GUARD trial of the Farapulse pulse field ablation (PFA) system after a pause reported in October “to assess a few unanticipated observations.” The trial aims to expand the indications for the market-leading PFA system to include a new population, drug-naïve patients with persistent atrial fibrillation.

South Korean researchers developed a novel quantum dot and parallel-stacked organic light-emitting diode (QD-PSOLED)-based wearable patch capable of being “freely tunable” in real-time, and described as a flexible and commercial-level technology with wide applications for health care wearables.

Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York.

Data from two Alzheimer’s tests being developed by Roche Holding AG showed high accuracy in detecting the disease in patients being tested for the condition. The tests measure biomarkers in the blood linked to Alzheimer’s and will help provide desperately needed information by letting patients know whether they have the disease or not, Margherita Carboni, Neurology Indication Lead at Roche Diagnostics told BioWorld.

A year out from Leqembi’s approval for Alzheimer’s disease (AD), ongoing research coupled with artificial intelligence is advancing both radiopharmaceuticals and small-molecule drugs for AD diagnostics and treatment, speakers at the 2024 KoNECT-MOHW-MFDS conference said.

Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York.

The first year of data from the TRISCEND II study of the Evoque tricuspid valve by Edwards Lifesciences Corp. confirm the notion that reduced regurgitation has a big impact on patient well-being. While one-year data support the device’s safety, cardiovascular mortality at one year does not seem to decisively favor the device over medical management.