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Subtle Medical's AI Imaging Tool Earns FDA Clearance


This device could make scans four times faster, according to the company.

Subtle Medical may market its new artificial intelligence (AI)-powered medical imaging system after receiving clearance from the U.S. Food and Drug Administration, according to an announcement.

Subtle Medical is a medical device company that uses deep learning imaging technologies to improve medical imaging efficiency and patient experience.

“We are not replacing radiologists — we are addressing the tremendous cost to U.S. healthcare by leveraging deep learning in imaging at the infrastructure level to enable better and higher quality care,” Enhao Gong, Ph.D., founder and CEO of Subtle Medical said.

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Its approved AI system, SubtlePET, allows hospitals and medical imaging centers to enhance images from faster scans. The device is currently in pilot clinical use in some university hospitals and imaging centers in the U.S. and abroad.

SubtlePET also secured approval to have the CE mark (certification) to market in the Europe without restrictions.

The technology scans a patient four times faster than normal, creating cost benefits for hospitals, said Michael Brant-Zawadzki, M.D., a neuroscience medical director at Hoag Hospital in California.

The company’s technology uses deep learning algorithms that integrate with scanners and picture archiving and communications systems to enhance images without interruption to specialists’ workflow.

Subtle Medical is currently developing more products to be submitted for FDA clearance.

SubtleMR uses AI solutions to accelerate MRI scans and SubtleGAD could reduce gadolinium dosage during imaging procedures.

“This FDA clearance is a key milestone in Subtle Medical’s mission to bring novel and empathetic deep learning to improve patient satisfaction,” Gong said.

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