The FDA issued a letter to the company declaring that it will not accept a letter of intent for the company's Parkinson's exam.
The test demonstrated 96% accuracy in a multi-site US clinical study of both adults and children 2 years and above.
It is an important step in furthering the agency's overarching dedication to the advancement of digital health technology.
CURE ID allows the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing drugs.
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.