Boston Scientific Corp. gained a second U.S. FDA approval for its Farapulse pulsed field ablation catheter, expanding its use into drug-refractory, symptomatic persistent atrial fibrillation (AF) in addition to its existing approval for paroxysmal AF. The expanded indication marks the first of several regulatory approvals the company expects in the coming months.
President Donald Trump signed House Resolution 1, the final version of which does not impose a moratorium on state legislation governing the use of AI. The bill does, however, restore the full deductibility of research and development expenses, which will be retroactive to 2022 for businesses that gross $31 million or less per year.
Accunea Ltd.’s bioanalysis technology, Renosure, can measure creatinine clearance in machine perfused kidneys, according to data presented at the recent European Society of Organ Transplantation 2025.
Australia’s Therapeutic Goods Administration reported June 30 several new regulatory requirements are in effect, including a new mandate regarding the use of unique device identifiers for implanted medical devices.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alcon, Allurion, Bio-Rad, Corflow, Fresenius Medical Care, Lumithera, Miach Orthopaedics, Novari Health, Panther, Vitalhub.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Morphic Medical, Sirtex Medical, Thermo Fisher Scientific.
Finding they were “arbitrary and capricious” under the Administrative Procedures Act, the District Court for the District of Columbia vacated a White House Office of Personnel Management memo and a subsequent Department of Health and Human Services’ guidance intended to implement President Donald Trump’s Day 1 executive order pertaining to gender ideology.
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