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Medical Devices / Submissions and Approvals

Subtle Medical Cleared for AI-Powered Imaging Tech

Dec. 7, 2018

Subtle Medical’s SubtlePET, a positron emission tomography (PET) imaging system driven by AI technology, was granted 510(k) clearance by the FDA. The device recently received a CE Mark in Europe.

The device can be used by hospitals and imaging centers to enhance images and speed up scanning times for PET scans.

Because the technology is able to reduce scanning times, it is capable of increasing the number of scans health care professionals can run each day.

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