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.
Seluna Ltd. launched a clinical study to validate its sleep diagnostic software, designed to support doctors to rapidly diagnose childhood sleep disorders and prioritize treatment for those who urgently need it. The study follows Seluna’s recent securing of nearly £650,000 (US$875,000) in funding.
A district judge has issue an Aug. 27 ruling enjoining Biosense Webster Inc. from tying its support for cardiac mapping equipment to purchases of the company’s catheters used in these procedures. According to the Association of Medical Device Reprocessors, the ruling triples previously announced damages, which will now cost Biosense nearly $450 million for violations of state and federal antitrust law.
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