BreastAI / InformaticsDevices & AI clearances

FDA Clears Screenpoint Medical’s Transpara 2.1.0 AI for Mammography

U.S. FDA1w ago

FDA cleared Screenpoint Medical’s Transpara 2.1.0 AI software for mammography via 510(k) premarket notification.

  • Transpara is an AI-based computer-assisted detection/diagnosis software for breast imaging.
  • The clearance (product code QDQ) covers a version update of the device.
  • The device was reviewed under the FDA’s radiology committee.
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