SubtlePET diagnostic device receives 510(K) clearance in US and CE mark approval in the EU.- Subtle Medical.
Subtle Medical announced 510(k) clearance from the FDA to market SubtlePET diagnostic device. Subtle Medical also recently secured approval to affix the CE Mark on SubtlePET to begin marketing in the European Economic Area without restrictions.
SubtlePET's artificial intelligence (AI)-powered technology allows hospitals and imaging centers to enhance images from faster scans leading to an improved patient experience during imaging procedures, while boosting exam throughput and provider profitability. SubtlePET is currently in pilot clinical use in multiple university hospitals and imaging centers in the U.S. and abroad.
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