The agency has released a discussion paper detailing how it plans to vet and approve AI medical devices without compromising quality or patient safety.
This means that the agency will consider AliveCor's technology on an accelerated clearance track.
The list includes Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily.
The initiative is designed to support and help develop FDA's Software Precertification (PreCert) Pilot Program.
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.
This is the first spirometer that was specifically developed as a home-use wireless connected spirometer that works with computers and mobile devices.
The device is available for purchase starting today, for $59.99 in-store at Best Buy and online at various retailers.
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.
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.
QbCheck provides unbiased and objective outcome measurements that can be utilized quickly and easily so that professionals are informed to act in ADHD.