In a significant boost to the Edwards Lifesciences Corp. Sapien 3 platform’s market opportunity, the U.S. FDA approved use of the transcatheter aortic valve replacement in patients with asymptomatic aortic stenosis. Read More
Deepull Diagnostics SL raised €50 million (US$56.93 million) in an oversubscribed series C financing round to complete clinical validation studies of its UllCORE diagnostic system for direct-from-blood rapid pathogen detection. Read More
Sen. Amy Klobuchar (D-Minn.) spoke to an industry meeting in Washington and expressed concerns about the situation at the U.S. FDA, but she also blasted the tariffs put in place by the Trump administration as lacking the proper statutory authority. Read More
Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health (CDRH), covered several programmatic areas in a May 1 trade association meeting, such as the CDRH early alert program. 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
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avenda Health, Castle Biosciences, Paragonix, Spectral AI. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivmentiv, Biocardia, Compco, Dova, ICU Medical, Innovative Lab Services, Otsuka, Satisfai. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Element Science, Intuitive. Read More
