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Subtle Medical receives CE mark for SubtlePET 2.0 to expand improved PET imaging capabilities

Press releases may be edited for formatting or style | June 09, 2021 Health IT Molecular Imaging
MENLO PARK, Calif., June 9, 2021 /PRNewswire/ -- Subtle Medical, a leading healthcare technology company using AI to improve the quality and efficiency of medical imaging, today announced CE Mark for the second generation of their SubtlePET™ image enhancement technology demonstrating improved performance, more applicable PET radiotracers and extended coverage for additional clinical applications. The software applies denoising to improve the image quality of low count PET (positron emission tomography) scans acquired in up to 25% of the original scan time, enabling centers to expedite patient care and improve patient comfort during PET exams.

There are over 2 million PET exams performed every year in the U.S. alone, and that volume is anticipated to increase with the recent FDA approvals for radionuclide therapies and an Alzheimer's treatment whose prerequisite is a positive Amyloid PET scan. Hospitals and imaging centers use Subtle's technology to assist in managing increasing scan volumes.

SubtlePET™ is FDA-cleared for use with 18F-FDG and 18F-Amyloid tracers and is now CE-marked for use with 18F-FDG, 18F-Amyloid, 18F-Fluciclovine, 18F-DOPA, 18F-Choline, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images, expanding coverage for Prostate (PSMA) and Neuroendocrine tumors. The vendor-neutral software is a virtual upgrade to any brand of PET or PET/CT machine that boosts scanner performance across the entire fleet.

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"By adding SubtlePET to our AI toolkit, we are dramatically increasing the efficiency of our nuclear medicine program and directly impacting the patient experience. We can scan a patient four times faster than normal, yet maintain excellent diagnostic image quality with SubtlePET, not otherwise impacting workflow," said Ravi Jain, MD, Ph.D, Radiologist at Middlesex Health. Subtle's technology helps support our commitment to patient care."

Attend Subtle's upcoming webinar to learn more: "Case Study Webinar with Middlesex Health: Ready-to-deploy AI Tools for Improving PET and MRI Imaging Efficiency and Patient Care" on Wednesday, June 30th at 10am PST / 1pm EST.

Several papers have been published on the clinical validation of SubtlePET™ in low count PET imaging. A recent study by nuclear medicine radiologists at Affidea in Italy was published in EJNMMI Physics demonstrating a reduction of 18F-FDG PET dose to 66% of standard produced images with non-inferior image quality when processed by SubtlePET™. The study involved a large patient cohort, multiple blinded reviewers, and "real world" data of native scans rather than simulation.

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