At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
The new approach is designed to create a connection between the left and right atrial chambers of the heart in a single ...
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...
Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the ...
Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device's ...
There's an urgent push underway to get the U.S. Food and Drug Administration to finally ban the devices that administer ...