Philips Medical Systems has been slapped with its second FDA warning letter in three months. The latest letter, received on October 16, takes the company to task for failing to inform the agency about 11 separate recalls involving a variety of products. All of the recalls were ranked as class II (medium-risk) recalls.
Philips Medical Systems has been slapped with its second FDA warning letter in three months. The latest letter, received on October 16, takes the company to task for failing to inform the agency about 11 separate recalls involving a variety of products. All of the recalls were ranked as class II (medium-risk) recalls.
Under FDA regulations, manufacturers and importers have 10 working days to notify the agency when they correct or remove a...
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.
