Approval of Cordis' Trufill liquid embolic agent should be conditioned on the company's completion of studies requested by FDA in an earlier deficiency letter on the firm's premarket approval application, the agency's Neurological Devices Advisory Panel agreed at its May 11 meeting in Gaithersburg, Maryland.
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.
EnsoData positions itself as device-agnostic and interoperable, with FDA-cleared software that can integrate with all major devices. CEO Mortara said this flexibility helps maximize patient reach by enabling both direct provider engagement and integration with device manufacturers.
After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.
