BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • BCI
    • Ebola outbreak
    • Hantavirus
    • Trump administration impacts
    • Med-tech outlook 2026
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • Bioworld 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Friday, July 31, 2026
View BioWorld MedTech
Home » U.S. AI med-tech regs in development 'not for the faint of heart'
To read the full story, subscribe or sign in.

U.S. AI med-tech regs in development 'not for the faint of heart'

Aug. 23, 2019
By Mark McCarty
The FDA's regulation of artificial intelligence (AI) is divided by product center for reasons that are obvious, but precisely what that regulation will look like is anything but. As the FDA's Center for Devices and Radiological Health (CDRH) goes through the comment period for its discussion draft for AI, other nations are starting their own efforts in this space. The American agency's efforts may foreshadow the approaches employed in other nations.
Medical technology Regulatory Artificial intelligence Digital health

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 30, 2026.
  • Illustration of dopamine signaling in the brain

    New schizophrenia targets challenge trial design

    BioWorld
    The search for better schizophrenia therapies is moving beyond dopamine toward a growing number of experimental targets. According to researchers, the repeated...
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for July 28, 2026
  • HIV virus

    AIDS 2026: New targets for metabolic dysfunction despite ART

    BioWorld
    Although antiretroviral therapy (ART) can suppress HIV to undetectable levels, a growing body of evidence suggests that the virus leaves a lasting biological...
  • Anthony Fauci at Senate hearing 7-29

    Fauci’s silence may put him in contempt of Congress

    BioWorld
    After repeatedly invoking the Fifth Amendment to every question asked during the July 29 hearing of the U.S. Senate Homeland Security Committee, Anthony Fauci,...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
    • Videos
Follow Us

Copyright ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing