The FDA has given a thumbs up to Id Core Xt, a molecular-based assay used in transfusion medicine to help assess blood compatibility. The assay can help determine blood donor and patient non-ABO red blood cell types. Id Core Xt is the second molecular assay approved for use in transfusion medicine, and the first to report genotypes as final results.
Irvine, Calif.-based Edwards Lifesciences Corp. reported the start of its U.S. pivotal trial evaluating the self-expanding Centera transcatheter valve for severe, symptomatic aortic stenosis patients at intermediate risk of open-heart surgery. The prospective, single-arm, multicenter study is expected to enroll about 1,000 patients and includes a bicuspid registry. The study has a composite endpoint of all-cause death and/or all stroke at one year.
This year has been a strong one in terms of med-tech IPOs. The sector saw the biggest debut in its history, with Siemens Healthineers. It appears as if the pace is not slowing down, with the last couple of weeks seeing two more companies report their first days of trading: Guardant Health Inc. and Ra Medical Systems Inc.
Israeli startup V-Wave Ltd. reported the start of enrollment in a study of a minimally invasive device to treat patients with New York Heart Association (NYHA) class III and ambulatory class IV symptomatic heart failure (HF).
Seattle-based Adaptive Biotechnologies Corp. won de novo clearance for its Clonoseq Assay to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples.
