The EU is having another go at improving access to capital for biotechs and science-based startups, in a bid to enable them to remain anchored in Europe. The Startup and Scaleup strategy, announced on May 28, is a response to the long-running problem that although Europe has strong foundations in its academic research, the innovative companies this science spawns often end up being acquired by U.S. companies, or moving to the U.S. to list on Nasdaq or the New York Stock Exchange.
The U.S. FDA granted 510(k) clearance to Distalmotion SA's Dexter, its surgical robotic system, for use in cholecystectomy in adults. The greenlight from the regulatory body is the second nod Dexter has received following de novo clearance granted in 2024 for use in inguinal hernia repair.
The U.S. FDA’s device guidance drought ended with the issuance of one draft and one final guidance, the latter of which deals with the Q-sub program for early interaction with sponsors of device applications. Per a request by industry, the agency indicated it is amenable to including FDA policy staff during these meetings, which may help to avoid surprises in premarket applications.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aesculap, Cardio Diagnostics, Cortigent, Darmiyan, Histosonics, Mapmygenome, MyID, Retrieve Medical Holdings, Seastar, Vivani Medical.
A court decision blocking President Donald Trump’s reciprocal and trafficking tariffs was hardly a day old before the U.S. Court of Appeals for the Federal Circuit stepped in late May 29 to grant a temporary stay while it considers the administration’s appeal. The stay adds further uncertainty to the path ahead for drug and device companies.
Researchers have identified KpsM as a virulence factor in Escherichia coli that was responsible for liver damage in alcohol-associated hepatitis (AH). A small-molecule inhibitor of KpsM reduced liver damage in animal models of AH.
Boston Scientific Corp. reported the latest setback in its transcatheter aortic valve replacement (TAVR) aspirations with the news that it is officially discontinuing worldwide sales of its Acurate neo2 and Acurate Prime systems
Shockwave Medical Inc. is confident that its intravascular lithotripsy (IVL) system can continue to dominate the market for calcium modification even as other technologies emerge, chief medical officer Nick West told BioWorld.