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.
IBM Blockchain

IBM Watson Health, FDA to study the use of blockchain for secure exchange of...

The two parties will explore the exchange of data from several sources, such as EMRs, clinical trials, genomic data, and health data from mobile devices.
Proteus Digital Health

FDA asks for more tests before it approves Proteus-Otsuka’s sensor-equipped pill

The two companies submitted the system as a new drug application (NDA) with the FDA in September 2015, and the Agency now declined to approve it.

FDA clears an online tool for diagnosing ADHD

QbCheck provides unbiased and objective outcome measurements that can be utilized quickly and easily so that professionals are informed to act in ADHD.