FDA clears a TytoCare 510(k) for its Tyto Insights for Rhonchi Detection, an artificial intelligence-based device for detecting all three major abnorm...
Chinese medical school researchers who analyzed cancer drug surrogate endpoint approvals in the U.S. and China say China appears to take a stricter ap...
Researchers say some issues need to be resolved if patient-reported outcomes are to be used as a surrogate in heart failure drug and device trials.
Citing concerns raised by a vascular surgeon when he was a CDRH medical reviewer, Harmed Americans for Reform in Medical Device Safety petitions FDA t...
FDA clears a Bright Uro 510(k) for its Glean Urodynamics System, a wireless, catheter-free ambulatory urodynamics device designed to support clinical ...
FDA approves Mirum Pharmaceuticals tablet formulation of Livmarli (maralixibat) for treating cholestatic pruritus.
Based on FDA recommendation, Ironwood Pharmaceuticals says it will conduct a new Phase 3 clinical trial for apraglutide for treating short bowel syndr...
