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FDA Clears Aramis Global's AI Renal Assessment Tool (AIRA V1)

U.S. FDA2w ago

The U.S. FDA has cleared the Artificial Intelligence Renal Assessment (AIRA) Version 1, a radiology AI device for renal assessment, via the 510(k) pathway.

  • The device is classified under product code QIH (radiological image processing system).
  • Cleared via the FDA's 510(k) premarket notification pathway by the Radiology committee.
  • Manufacturer: Aramis Global AI Consultancies, LLC.
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