SubtlePET 2.0 Gets CE Mark

Subtle Medical 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.

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.

"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, PhD, Radiologist at Middlesex Health. Subtle's technology helps support our commitment to patient care."

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.

"AI is becoming the standard of care in radiology departments worldwide. We're excited to have the opportunity to both empower radiologists with efficiency tools that help expedite patient care and help them provide a better patient experience. By receiving the CE Mark for SubtlePET's expanded coverage, a greater impact can be felt across an even larger patient population," said Enhao Gong, PhD, Founder of Subtle Medical.

The company's technologies utilize proprietary deep learning algorithms that integrate seamlessly with any OEM scanner and PACS system to enhance images during acquisition without any interruption or alteration in the imaging specialists' workflow.

"Our products directly support our mission to improve access to faster, safer, and smarter diagnostic imaging," said Josh Gurewitz, Chief Commercial Officer at Subtle Medical. "We are dedicated to pushing the boundaries of new AI based products as well as continuously improving our existing product line with new features and capabilities. These continuous advancements will provide patients a significantly better patient experience."

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