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BioWorld - Thursday, July 7, 2022

SAMD

Home » Topics » Software » SAMD
  • Fda  not approved stamp
    June 24, 2022
    By Tamra Sami

    FDA rejects Artrya’s 510(k) for its AI-enabled Salix coronary anatomy software

    The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
  • Brazil flag
    May 27, 2022
    By Sergio Held

    Brazil readies to adopt SaMD regulation

    Brazil’s health care regulator plans to start enforcing in July new regulations for software as a medical device (SaMD), clearing up doubts about its oversight over intangible health care assets such as software.
  • Asia singapore
    May 20, 2022
    By David Ho

    Singapore updates guidelines for software as medical devices to expand scope

    Singapore’s Health Sciences Authority (HSA) recently updated its guidelines for software as medical devices (SaMDs) to broaden its scope on a number of related matters. The new guidelines were finalized after an industry input period when the HSA collected feedback until the middle of August 2021. It marks the second revision of HSA guidelines on SaMDs, the first revision was meted out in April 2020. 
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Authors

  • Tamra Sami
  • Mark McCarty
  • Annette Boyle
  • David Ho
  • Zhang Mengying
  • Sergio Held
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