US Food and Drug Administration (FDA)
FDA Seeks Feedback on Technologies That can Enable Healthcare at Home
Dive Brief: Dive Insight: The development of remote patient-monitoring devices and other connected medical technologies has made it possible to treat more patients at home. In theory, home care can help reduce costs and risks associated with spending time in healthcare facilities and lessen burdens on patients. The COVID-19 pandemic accelerated uptake and validation of telehealth […]
Nonagon Receives FDA Clearance for Over-the-Counter Remote Examination Platform, Making Healthcare More Accessible
Nonagon Enables Clinical-Grade Remote Examinations for Heart, Lungs, Abdomen, and More, Potentially Improving Health Outcomes and Reducing Hospital Visits CAESAREA, ISRAEL, April 19, 2023/EINPresswire.com/ — Nonagon, a fast-growing medical device company based in Israel and the US, has received FDA clearance to sell its N9+ device as an over-the-counter product, making remote patient examinations more […]
The Long (Un)Winding Road: FDA Maps Out How the End of the Public Health Emergency Will Impact its COVID-19 Policies
Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be available to manufacturers of medical devices, drugs and biological products, and foods during the public health emergency. Several of these guidance documents have been modified, updated, […]