Ellume COVID 19 self-test

FDA greenlights Ellume COVID-19 Home Test

The test demonstrated 96% accuracy in a multi-site US clinical study of both adults and children 2 years and above.
FDA Digital Health Center of Excellence

FDA launches the Digital Health Center of Excellence

It is an important step in furthering the agency's overarching dedication to the advancement of digital health technology.
CURE ID

FDA’s new app lets physicians report novel uses of existing medicines

CURE ID allows the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing drugs.
FDA

FDA unveils a framework for reviewing AI-based medical devices

The agency has released a discussion paper detailing how it plans to vet and approve AI medical devices without compromising quality or patient safety.
AliveCor KardiaMobile

AliveCor’s bloodless hyperkalemia test scores the “Breakthrough Device” designation from the FDA

This means that the agency will consider AliveCor's technology on an accelerated clearance track.
FDA precertification pilot

FDA selects 9 companies for its precertification pilot

The list includes Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily.
FDA logo

FDA looking for digital health innovators for an entrepreneur-in-residence program

The initiative is designed to support and help develop FDA's Software Precertification (PreCert) Pilot Program.
FDA graphic

FDA’s digital health pre-certification pilot program is now open for applications

The focus of the Pre-Cert program is not on particular products but on firms and developers, which in turn (if pre-certified) will be able to more easily certify all of their products.
GoSpiro home-use spirometer

Monitored Therapeutics’ GoSpiro Home Spirometer clears the FDA

This is the first spirometer that was specifically developed as a home-use wireless connected spirometer that works with computers and mobile devices.
John Bedell Photography

FDA clears VivaLnk’s wearable thermometer Fever Scout

The device is available for purchase starting today, for $59.99 in-store at Best Buy and online at various retailers.