Subtle an AI based Medical Device SubtlePET Receives FDA’s 510(K) Clearance

 Subtle an AI based Medical Device SubtlePET Receives FDA’s 510(K) Clearance

Subtle an AI based Medical Device SubtlePET Receives FDA’s 510(K) Clearance

Shots:

  • SubtlePET is a medical device based on AI technology has received FDA approval, after EU approval. SubtlePET is used for medical imaging with rapid scans and utilizes algorithms that integrate with OEM scanner and picture archiving and communication system (PACS)
  • The device enables to scan four times faster scans than current technology with improved image quality, better understanding of results in less time
  • Subtle is developing two AI based technology SubtleMR & SubtleGAD: used to fasten MRI scans and to reduce gadolinium dosage during imaging procedures respectively

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