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.
The doctrine of inherent disclosure is not one of the more common methods for invalidating patent claims, but this doctrine led the U.S. Court of Appeals for the Federal Circuit to declare that several claims found in a patent held by Carl Zeiss X-Ray Microscopy Inc. are invalid.
EBR Systems Inc. raised AU$55.9 million (US$36 million) to commercialize its Wise cardiac resynchronization therapy system following U.S. FDA approval in April of the wireless, endocardial pacing system to stimulate the heart’s left ventricle.
RSS
