Digital Health: FDA’s Shuren Predicts ‘Critical Regulatory Hurdles’ If Congress Doesn’t Update Reg Frameworks

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.