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November 25, 2020

FDA grants 510(k) clearance to CorticoMetrics’ AI neuroimaging software

The US Food and Drug Administration (FDA) has granted 510(k) clearance for CorticoMetrics’ AI-based software, THINQ, for MRI brain volumetric reporting.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for CorticoMetrics’ AI-based software, THINQ, for MRI brain volumetric reporting.

THINQ can provide radiologists and neurologists with quantitative information to improve assessment of various neurological disorders and conditions in patients.

The software can automatically segment T1-weighted MRI brain image, providing volumetric measurements and visualisations of 30 critical brain structures.

These measures are then compared with age and gender-matched reference percentile data.

Brain images with colour-coded segmentations and plots showing how measurements are compared to reference data are included in the reporting.

CorticoMetrics co-founder and CEO Nick Schmansky said: “THINQ reporting aids the workflow of radiologists and neurologists, aiming to increase examination throughput and improve the overall quality of the patient outcome.”

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In a separate development, the FDA approved Braid Health’s AI-powered diagnostic collaboration software.

The platform increases diagnostic access and cuts down costs for large healthcare systems, urgent care clinics and retail clinics.

The traditional imaging process is plagued by delays and lack of provider-patient communication.

Braid’s mobile application allows providers and radiologists to access, review, and annotate images and share results with patients in realtime from any mobile device.

The software, integrated with AI for providing quality assurance, aids providers to prevent errors and provide highly accurate interpretations.

Braid Health chief medical officer Rajni Natesan said: “The Braid platform puts cutting-edge consumer technology directly into the pocket of providers and patients, fundamentally raising the bar on quality when it comes to patient care.

“Leveraging the Braid platform, providers have the ability to facilitate care in a timely and collaborative manner, while allowing patients to continue their care journey seamlessly across health systems and providers.”

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