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Subtle Medical Receives CE Mark for SubtlePET™ 2.0 to Expand Improved PET Imaging Capabilities

The technology now has expanded coverage for Prostate (PSMA) and Neuroendocrine tumor targeting agents

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.

Equivalent diagnostic image quality with SubtlePET AI
Equivalent diagnostic image quality with SubtlePET AI

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-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, 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. Visit Subtle’s scientific presentations at SNMMI.

“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, Ph.D, Founder of Subtle Medical.

SubtlePET is in commercial use in multiple hospitals and imaging centers worldwide to improve the image quality of routine and accelerated PET protocols. In light of the Covid-19 pandemic, this allows centers more time for additional cleaning procedures in between patients and addresses the backlog of imaging procedures from postponed appointments. Download a case study.

“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.”

Subtle Medical has an extensive product pipeline. 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.  For information on additional products, click here.

About Subtle Medical
Subtle Medical, Inc. is a healthcare technology company with deep learning software solutions that increase the quality and efficiency of medical imaging. It was named a CB Insights Top AI 100 and Digital Health 150 company in 2020 and is an Nvidia Inception Award Winner. Current clinical partners include UCSF, Hoag Hospital, Mount Sinai, Sickkids, Radnet, Affidea, DASA, Tiantan Hospital, and Middlesex Hospital, among others. For more information, please visit subtlemedical.com or email sales@subtlemedical.com.

Media Contact:
Anna Menyhart-Borroni
Head of Marketing