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Subtle Medical closes RSNA with CE mark and FDA clearance of PET AI solution

por John W. Mitchell, Senior Correspondent | December 06, 2018
Artificial Intelligence Molecular Imaging
The SubtlePET AI algorithm speeds up
scans by a factor of four
(Photo courtesy of Subtle Medical)
Subtle Medical closed the week of RSNA 2018 on a high note, receiving the go-ahead from the FDA to begin distribution of its SubtlePET AI algorithm just one day after the event’s conclusion, as well as CE marking for the product during the conference.

The deep-learning software is designed to enhance image quality and accelerate PET scans by a factor of four, enabling providers and imaging centers to obtain findings in shorter time spans.

“The ability to complete more exams in a day without the need for capital expenditures for added scanners, and attract more patients due to a better experience, helps hospitals and imaging centers enhance their bottom line in today’s competitive healthcare environment,” Subtle Medical co-founder and deep-learning expert Enhao Gong told HCB News.
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Targeting the technical aspect of image generation rather than interpretation, SubtlePET integrates seamlessly into the existing imaging clinical workflow to offer more sensitive and refined images.

It is currently being deployed in pilot clinical use at several academic and outpatient sites in the U.S. and worldwide.

In addition to the FDA clearance, Gong and co-founder Greg Zaharchuk, a Stanford radiology professor, gave seven talks and sat on panels at the conference.

Another big highlight for them was being awarded the RSNA “Trainee Research Prize” in recognition of their work to develop an AI solution aimed at reducing dosage of the contrast agent, gadolinium. Recent studies have revealed that traces of the heavy metal can remain in the brain after imaging exams. In their own study, Gong and Zaharchuk observed no difference in image quality between scans that utilized the lower dose Subtle AI platform and those with higher gadolinium dose.

“Our broad range of scientific advisors provides us with first-hand clinical advice to work on the right questions with the biggest clinical impact using AI, and to evaluate the performance,” said Gong. “From the experts in imaging physics and AI, we have advantages of leading the area with state-of-art AI technologies.”

Subtle medical’s scientific advisers include representatives from Stanford, the University of Chicago, MD Anderson Cancer Center, Hoag Memorial Hospital, and Massachusetts General Hospital.

Gong expects to soon begin distribution of the SubtlePET AI platform to hospitals and clinics in Europe and the U.S.

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