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FDA Clears Subtle Medical's AI-Powered Image Enhancement Software

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Subtle Medical today announced its artificial intelligence (AI)-powered image processing software, SubtleMR, received 510(k) clearance from the U.S. Food and Drug Administration (FDA). SubtleMR uses deep learning algorithms, denoising and resolution enhancement to improve the image quality of existing scanners. "We are pleased to received FDA clearance for SubtleMR, and we look forward to helping radiology departments and imaging centers get the most out of their existing MRI scanners," said Enhao Gong, Ph.D., founder and CEO of Subtle Medical. The software, which Subtle Medical said is compatible with any brand of MRI scanner and picture archiving and communication systems (PACS), could be beneficial for patients who have trouble staying still for long periods of time. Reducing the scan time for these patients not only improves the patient experience but could result in fewer artifact-ridden images and the need for physicians to re-scan an individual.


Subtle Medical Receives FDA 510(K) Clearance for AI-Powered SubtleMR

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"One of the most exciting things about deep learning reconstruction is how it redefines the usual negotiation between exam time and image quality. This could lead to significant downstream value for imaging operations and for patient experience," said Christopher Hess, MD, Chair of the Department of Radiology and Biomedical Imaging at UCSF. SubtleMR delivers a significant improvement in the quality of noisy images, which is particularly beneficial for patients who have difficulty holding still for long periods of time. Artifact-ridden images and the need for re-scans are a challenge for both patients and physicians. SubtleMR integrates seamlessly into the radiology workflow, and it is compatible with any brand of MRI scanner and PACS.


Subtle Medical Receives FDA 510(k) Clearance for AI-Powered SubtleMR

#artificialintelligence

"One of the most exciting things about deep learning reconstruction is how it redefines the usual negotiation between exam time and image quality. This could lead to significant downstream value for imaging operations and for patient experience," said Christopher Hess, MD, Chair of the Department of Radiology and Biomedical Imaging at UCSF. SubtleMR delivers a significant improvement in the quality of noisy images, which is particularly beneficial for patients who have difficulty holding still for long periods of time. Artifact-ridden images and the need for re-scans are a challenge for both patients and physicians. SubtleMR integrates seamlessly into the radiology workflow, and it is compatible with any brand of MRI scanner and PACS.