Apple has told participants in its heart study that their data will be used to seek FDA approval for an investigational device.
The FDA nod gives doctors an updated tool for monitoring the state of the brain in anesthetized and sedated patients.
The designation sets MedyMatch up to receive advice from the FDA as it goes about advancing the software toward a filing for approval.
Paris-based SafeHeal has begun a CE mark study for its Colovac device that is designed to be used as a bypass after a rectal resection.
Gottlieb thinks revisions are needed to give the FDA authorities that are a better fit for modern diagnostics than the current 510(k) pathway.
Officials put the rule forward to enable earlier Medicare coverage of medical devices, only to withdraw it nine months later.
The regulatory nod marks the first time the CFDA has cleared a plasma-based EGFR mutation companion diagnostic for use.
Adhesys Medical, a surgical adhesive company, said it has received a CE mark for its Mar-Cutis Flix topical skin adhesive for surgical use.
The 510(k) nod positions Surmodics to start shipping a device designed for use in the treatment of complex coronary and peripheral lesions.
Surgeons can now use the flexible scope to visualize and access sites in procedures that start with incisions to the abdomen or thoracic cavity.