Subtle Medical's SubtlePET granted FDA 510(k) clearance, CE mark approval

Subtle Medical announced Wednesday that its artificial intelligence (AI)-powered technology SubtlePET received FDA 510(k) clearance, marking the "first AI product cleared for medical imaging enhancement." SubtlePET, which also recently received CE mark approval, "allows hospitals and imaging centres to enhance images from faster scans leading to an improved patient experience during imaging procedures, while boosting exam throughput and provider profitability," the company said.

CEO Enhao Gong remarked that "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 added that "we are not replacing radiologists--we are addressing the tremendous cost to US healthcare by leveraging deep learning in imaging at the infrastructure level to enable better and higher quality care."

According to Subtle Medical, the AI technology, which is in pilot clinical use in multiple university hospitals and imaging centres in and outside the US, reduces patient time in the scanner, allowing more exams to be completed each day "compared to conventional PET imaging without the need for capital expenditures." The technology uses deep learning algorithms that integrate seamlessly with current scanners and "delivers a significant improvement in the image quality of noisy images resulting from shorter scans, which is particularly beneficial for children and those undergoing repeat PET exams," the company added.

Subtle Medical further noted that it is developing additional products to be submitted for FDA clearance, including SubtleMR, which is undergoing clinical evaluation and allows imaging centres to significantly accelerate MRI scans using the company's AI solutions. Subtle Medical said it is also developing SubtleGAD to reduce gadolinium dosage during imaging procedures.

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