The U.K. Medicines and Healthcare Products Regulatory Agency announced a new pilot program for modifications to clinical trials that allows for automatic approvals of those changes based on the risks those changes present.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Brightheart, First Ascent, Iantrek, Inflammatix, Zoll.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accelus, Alcon, Alpha Tau, Biotia, Care Advantage, Carenova, Congencia, Foresight Diagnostics, Highridge, Måna Care, Neurophet, Predicine, Roche, Seqone, Solventum, Staar Surgical, Themo Fisher Scientific.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Coagusense, Geneseeq Technology, Hyperfine, Imperative Care.
Edwards Lifesciences Corp. execs no doubt danced a little jig on the release of the latest European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines for valvular heart disease. The update established a simplified pathway for severe aortic stenosis (AS) that eliminated the previous divide between symptomatic and asymptomatic severe AS.
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