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Funding in the fiscal 2024 budget to make sure the U.S. is prepared for potential medical device shortages is one of the top concerns for the FDA’s Center for Devices and Radiological Health (CDRH), according to CDRH Director Jeff Shuren. Read More
Roche has teamed up with Eli Lilly to develop Roche’s Elecsys Amyloid Plasma Panel (EAPP), an investigational blood-based biomarker test designed to give patients an earlier Alzheimer’s disease diagnosis. Read More
The FDA has updated its device shortage list to reflect changes in the estimated shortage durations for six categories of medical devices, continuing its monitoring of the supply chain in light of the high demand and shortages resulting from the COVID-19 public health emergency.
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.