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.
Patients often wait for a long time to see a mental health specialist to get the help they need, and Greymind AI’s mental health platform, Reboot AI, offers a stop-gap measure to provide structured early intervention with built-in escalation to human clinicians.
Researchers from the University of California, Davis (UC-Davis) continue to assemble intellectual property in support of their development of methods and techniques which improve the accuracy of wearable sensor technologies.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Embla Medical, Natera, Neogenomics, Streifeneder ortho.production.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott Laboratories.
Two days after the ouster of Susan Monarez as CDC director on Aug. 27, HHS confirmed to BioWorld that James O’Neill is serving as acting director. O’Neill was previously Deputy Secretary of Health and Human Services. He has also served as the CEO of the SENS Research Foundation, which merged with Lifespan.io in 2024. The resulting Lifespan Research Institute describes itself as “focused on the defeat of age-related disease and the extension of healthy human lifespan” on its website.