The FDA’s Center for Diagnostic and Radiological Health (CDRH) has released a schedule of upcoming enhancements to its Electronic Medical Device Reporting (eMDR) system to provide early notice to manufacturers.
Two recent studies found that the DermaSensor skin cancer detection device showed a 94 percent sensitivity for correctly classifying high-risk skin cancer lesions, exceeding the accuracy of primary care physicians (PCPs).
The Centers for Medicare and Medicaid Services (CMS) has given Applied VR a unique payment code — the first for a virtual reality (VR) device — for its RelieVRx, providing a pathway for Medicare and Medicaid to cover the device as durable medical equipment (DME).
Burlington, Mass.- based LeMaitre Vascular drew a lengthy Form 483 from the FDA for failing to follow the company’s own corrective and preventive action (CAPA) procedure and to control nonconforming product, among other lapses.
The FDA has issued a warning letter to Tokyo-based endoscope manufacturer Olympus Medical Systems for failing to establish procedures to implement corrective and preventative actions as well as a lack of process validation for product changes, among other lapses.
As part of its Medical Device User Fee Amendments (MDUFA) goals for 2023-2027, the FDA’s Center for Diagnostic and Radiological Health (CDRH) has added new functions to its portal where device sponsors can send in and track their premarket submissions.