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.
Johnson & Johnson received U.S. FDA investigational device exemption to begin the pivotal clinical trial for the Ottava robotic surgical system. If the trial goes well, Ottava could pose a significant challenge to decades-long dominance of the robotic surgical market by Intuitive Surgical Inc.’s Da Vinci system.
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.
Almost a year after U.S. FDA approval of the first pulsed field ablation device for treatment of atrial fibrillation, Johnson & Johnson secured FDA approval for its Varipulse system, intensifying competition in the rapidly growing market.
Prognomiq Inc. secured $34 million in a series D funding round to advance development of an early detection test for lung cancer based on its multiomics platform. The blood-based test could provide an alternative to the underutilized low-dose CT scans currently recommended for individuals at high-risk of lung cancer.
Qiagen NV added to its growing roster of panels cleared by the U.S. FDA in 2024 with the agency’s nod for its Qiastat-Dx Meningitis/Encephalitis assay. The clearance validates Qiagen’s strategy of developing rapid tests specifically for the U.S. market and builds on the respiratory, gastrointestinal and central nervous system tests already available.
Boston Scientific Corp. signed a definitive agreement to acquire Cortex Inc., from Ajax Health Inc. to develop an integrated mapping and ablation solution for cardiac arrhythmias. Cortex’s Optimap system employs a basket catheter and algorithm to identify active sources for atrial fibrillation beyond the pulmonary veins on which most mapping and ablation technology currently focus.
Two recent trials in cardiovascular disease took critical steps toward addressing ongoing and deadly disparities in cardiac care by focusing entirely on women.
Abionic SA received U.S. FDA 510(k) clearance for its in vitro diagnostic Capsule pancreatic stone protein (PSP) sepsis test. Produced by the pancreas and immune cells, PSP provides an early biomarker for sepsis that could push back detection of deadly condition by 24 to 48 hours.
