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Subtle Medical announced Tuesday the FDA 510(k) clearance of its image processing software SubtleMR, which the company said is the first artificial intelligence (AI) product cleared for magnetic resonance image (MRI) enhancement. SubtleMR is currently in pilot clinical use in multiple university hospitals and imaging centres.
CEO Enhao Gong remarked that "we look forward to helping radiology departments and imaging centres get the most out of their existing MRI scanners," adding that the clearance "is an important milestone for the company as it broadens our portfolio of technologies developed for radiologists and their patients."
According to Subtle Medical, the software uses denoising and resolution enhancement, along with deep learning algorithms to improve image quality produced by existing scanners. The company added that SubtleMR "integrates seamlessly" into the radiology workflow, and is compatible with any brand of MRI scanner and picture archiving and communication system.
Last December, Subtle Medical announced that its SubtlePET technology received FDA 510(k) clearance as well as CE mark approval. According to the company, the product leverages AI to speed up positron emission tomography scan times four-fold. Meanwhile, SubtleGAD, its third product in development, "has the potential to reduce gadolinium dosage during contrast-enhanced MRI exams." Subtle Medical was recently awarded a $1.6-million grant from the US National Institutes of Health to further its research on this technology.
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