FDA clears iCat Solutions' mobile DICOM viewer

Norwich, U.K.-based mobile app firm iCat Solutions has received clearance from the U.S. Food and Drug Administration (FDA) for its Falcon MD mobile DICOM viewer.

Falcon MD is cleared for diagnostic interpretation performed entirely on-device and is compatible with all advanced image processing, according to iCat. The clearance builds on prior FDA clearance the company received for Falcon MD for Mac computers by extending it capabilities to both iPhone and iPad platforms, the company said.

Falcon MD (mobile) features include the following:

  • On-device 3D multiplanar reformatting and photorealistic volume rendering – no server-side processing or streaming
  • Full compatibility with CT, MRI, computed radiography, ultrasound, and other DICOM formats
  • Local storage and rapid loading of studies for offline diagnostic review
  • Regulatory-compliant performance backed by FDA clearance
  • A unified codebase with Falcon MD for Mac, ensuring consistency across platforms

The app is will be will be available on the App Store this summer and is intended for environments where access to traditional workstations is limited or unavailable, iCat noted.

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