NewsDialy
Some medical devices that use artificial intelligence to make care decisions can now reach patients before their makers have received marketing authorization, the formal federal clearance that normally must precede any commercial sale of a medical product.
The Food and Drug Administration is running this experiment through a pilot called TEMPO, which has accepted four devices so far, including AI products from Cadence and Limbic.
What the TEMPO pilot is and why it exists Marketing authorization is the FDA's standard gatekeeper step. Without it, a device cannot legally go to market.
The TEMPO pilot suspends that requirement for a specific purpose: expanding the pool of technologies available under the Medicare ACCESS model.
Keep reading