Echoing President Trump's ongoing call to fight the opioid-abuse epidemic, the US agency is asking medtech companies to submit applications for new products to tackle the issue. Promising devices and diagnostic tools identified by the agency will get extra attention from FDA, but they won't have to submit an additional application for a Breakthrough Device designation.
As the Trump administration continues to fight the opioid epidemic, US FDA has issued a challenge to medtech companies: Come up with solutions to the crisis and your product could be expedited to market through the agency's pre-market review process.
On May 30, FDA posted a challenge to medical device and diagnostics companies to present it with proposals for combatting...
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.
