Pulse Biosciences Inc. presented late-breaking results from its successful first-in-human study of its nanosecond pulsed field ablation technology in treating atrial fibrillation at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark. The Hayward, Calif.-based company’s Npulse cardiac surgical system takes PFA technology into the cardiac surgery setting. Read More
Vektor Medical Inc. recently secured CE mark for Vmap, its AI-powered electrocardiogram mapping system, marking a “major milestone” for the company, said CEO Rob Krummen. The regulatory approval from the EU authorities confirms that Vmap meets the stringent safety and performance requirements of the EU Medical Device Regulation, opening the door for clinical use in Europe, he told BioWorld. Read More
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) reported that it will seek to deepen its collaboration with other regulators, a list that includes but is not limited to the FDA. MHRA said that the U.K.-U.S. reliance program would apply to not only class II devices under the 510(k) and de novo programs, but to class III PMA devices as well, promising a somewhat more streamlined path to a market ripe with opportunity for the devices and diagnostics industries. Read More
Pomdoctor Ltd. raised $20 million through a Nasdaq IPO on Oct. 8, with the funds geared to expand its mobile health platform for chronic diseases in China. Read More
BioWorld Staff Writer Randy Osborne reflects on the transformative progress in gene therapy – from tools like CRISPR and AAV vectors to major breakthroughs in diseases like hemophilia, sickle cell and beta-thalassemia. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amplifi Vascular, Inspire Medical, Neurent Medical, Pulse Biosciences. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agilent, Berlin Heals, Infinx Healthcare, Natus Sensory, Seqwell, Scanogen, Smith+Nephew, SPT Labtech, Tikak, Voxology AI, Work Medical, Ypsomed. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Surgical Theater. Read More
