The U.S. FDA has granted 510(k) clearance to Menlo Park, Calif.-based Subtle Medical to market its SubtlePET artificial intelligence (AI) technology. The product, which has also secured the European CE Mark, is currently in pilot clinical use in multiple university hospitals and imaging centers in the U.S. and abroad.

“Focusing Subtle Medical’s SubtlePET AI platform on faster image acquisition, we have been able to dramatically increase PET scan efficiency and provide a superior patient experience. SubtlePET technology allows us to scan a patient four times faster than normal, yet maintain equal image quality, not otherwise impacting work flow,” says Michael Brant-Zawadzki, MD, FACR, of Hoag Hospital in Newport Beach, Calif. “This creates immediate ROI benefit for our hospital and a compelling value proposition. I’m looking forward to seeing more groundbreaking technology from the Subtle team.”

The company’s technology utilizes deep learning algorithms that integrate with any OEM scanner and PACS to enhance images during acquisition. According to company officials, SubtlePET boosts the quality of noisy images, thus resulting in shorter scans—something that could benefit children and those undergoing repeat PET exams.

SubtlePET is Subtle Medical’s first AI product to receive FDA clearance. “This FDA clearance is a key milestone in Subtle Medical’s mission to bring novel and empathetic deep learning to improve patient satisfaction,” says Enhao Gong, PhD, founder and CEO of Subtle Medical. “The accomplishment of having the first AI cleared for use in nuclear medicine applications validates our team’s strength and the commitment of our collaborators.”

“Our focus on image acquisition and workflow differentiates us from other AI companies that are working on post-processing and computer-aided diagnosis products,” Gong adds. “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.”

Subtle Medical is developing additional products to be submitted for FDA clearance. A second product currently undergoing clinical evaluation is SubtleMR, which allows imaging centers to significantly accelerate MRI scans using the company’s AI technology. SubtleGAD is also being developed to reduce gadolinium dosage during imaging procedures.