HEALTH 2.0 13TH ANNUAL CONFERENCE | SANTA CLARA, CA | SEPT. 16-18, 2019

FDA Clears AI-Based Healthcare Tools, Systems

By Heather Munro, freelance writer focusing on emerging technology.

There’s no denying the potential of digital health technologies to empower consumers to make better-informed decisions about their own healthcare. On January 7, Healthcare IT News reported that the Food and Drug Administration (FDA) officially—finally—began working toward a more streamlined approval process for artificial intelligence and other digital health products with the release of The Digital Health Innovation Action Plan.

Part of the FDA’s Pre-Cert Pilot Program to review potential products, the plan is a huge step forward in modernizing the agency’s oversight of digital health tools.  Artificial intelligence (AI), in particular, is expected to benefit, with the healthtech entrepreneurs already developing tools to help human providers in everything from providing faster service, diagnosing diseases, and analyzing genetic data.

To learn more about the innovative companies already pursuing 510(k) and De Novo approvals with the agency, read “Roundup: 12 healthcare algorithms cleared by the FDA” on MobiHealthNews.

 

Read more at MobiHealthNews

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