On Thursday, the FDA Center for Devices and Radiological Health released updated final guidance for its Breakthrough Devices Program, aimed at verifying medical devices on the market are safe and effective, and improve healthcare inequities.
The final guidance defines the FDA's interpretation of "more effective" as encompassing all the information about the device, including the risks and...
The FDA on Thursday released draft guidance for its Breakthrough Devices Program aimed at reducing health disparities.
The draft proposes updates that would clarify how the program would apply to medical devices that could benefit groups affected by health inequities, including disparities based on race, sex, ethnicity and access to care. The agency will also assess if the developers have...
Led by Ally Bridge Group and with the help of its existing shareholders, venture-backed Ceribell, Inc. has raised $50 million.
The funding was structured as an extension of its $53 million Series C raise, which was announced in April 2021.
WHAT IT DOES
Ceribell developed a rapid response electroencephalography (EEG) system to make diagnosing neurological patients more efficient. It says that its...
