Vivasure Medical Ltd. received CE mark approval for its Perqseal Elite vascular closure system which manages bleeding complications associated with large-bore arterial vessel closure. The sutureless, fully bioresorbable device has the potential to reduce problems associated with traditional closure methods in patients undergoing complex structural heart procedures. Read More
The Heart Rhythm Society and American College of Cardiology published guidance for same-day discharge of cardiac ablation patients during Heart Rhythm 2025, the society’s annual meeting, which was held in San Diego April 26-27. Read More
Using step counts and heart rate readings from Google’s Fitbit devices, a machine learning model accurately predicted the risk of hospitalization, a study presented at Heart Rhythm 2025 found. The study used data from participants in the National Institutes of Health’s All of Us research program. Read More
The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence. Read More
The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the uncertainty, BioWorld continues to cover the administration’s latest policy decisions and actions affecting the life sciences sector, as well as their impacts across the globe. It’s all right here at Trump administration impacts. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accustem Sciences, BHM, Emeritus Medical, Mainstay Medical, Sensydia, Sonitus Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clarius Mobile Health, Medtronic. Read More
