Medical device company Subtle Medical has recently received 510(k) clearance from the FDA for SubtlePET, their AI powered imaging technology. These approvals give Subtle Medical the ability to commercialize their technology throughout the US and European regions.
SubtlePET AI has been created to optimize images generated by scans in hospitals and imaging centers. This system will not only improve patient experiences during these imaging procedures but will enhance scan throughput and provider profitability as well.
SubtlePET is currently in pilot clinical use in several imaging facilities and university hospitals in both the US and overseas. Subtle Medical claims that this new AI solution increases imaging rates, allowing more exams to be performed per day compared to the traditional PET imaging system.
“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. 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,” said Dr. Michael Brant-Zawadzki of Newport Beach, California-based Hoag Hospital said in a prepared statement.
The SubtlePET is reported to reduce the time a patient spends in the scanner as well, not only allowing imaging facilities to handle more patients, but making the experience better for these patients as well.
Subtle Medical is also developing other products that it will seek FDA clearance for, one of which being a similar AI system for MRI scans. Another system they plan to implement is the SubtleGAD, designed for gadolinium dosage during imaging procedures.
“This FDA clearance is a key milestone in Subtle Medical’s mission to bring novel and empathetic deep learning to improve patient satisfaction. 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. 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,” said founder & CEO Enhao Gong in a press release.
We are thrilled to announce that Subtle Medical received FDA 510(k) Clearance & CE Mark Approval for our product, SubtlePET™! SubtlePET is the very first AI product the FDA has cleared for medical imaging enhancement. #milestone #radiology #AI #getready https://t.co/Zdr46MSFKg
— Subtle Medical, Inc. (@SubtleMedical) December 5, 2018