510(k)

CorticoMetrics’s THINQ Receives the US FDA’s 510(k) Clearance for MRI Brain Volumetric Reporting

Shots: The US FDA has granted 510(k) clearance for CorticoMetrics’ AI-based software, THINQ, for MRI brain volumetric reporting. The software can provide radiologists & neurologists with quantitative to improve assessment of neurological disorders The software can automatically segment T1-weighted MRI brain image, providing volumetric measurements & visualisations of 30 critical brain structures and compares the …

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Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

Shots The FullFocus viewer allows pathologists to view and navigate images when used together with the Philips’ Ultra-Fast scanner. The AI firm is working to expand the 510(k) clearance to include the use of FullFocus with additional scanners and monitors in future In Nov’2019, FullFocus received the CE Mark, making it available to use in …

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