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The FDA’s Special 510(k) application review can offer devicemakers the path of least resistance to market clearance, an official from the FDA’s Center for Devices and Radiological Health (CDRH) said, as long as the device meets specific criteria. Read More
Clare Medical of New Jersey reported in a recent study that its proprietary artificial intelligence (AI) tool that identifies elderly patients with a high probability of needing an emergency room (ER) visit or hospitalization within 30 days reduced these visits by 77 percent. Read More
In a new procedural document released on Wednesday, the FDA directs its Office of Generic Drugs (OGD) to request additional data from sponsors of generic drug-device combination products if the generic product’s user interface is substantially different from the original product. Read More
The modular system is compatible with existing patient data consoles, surgical displays and endoscopes used in minimally invasive operating rooms. Read More