Saturday, December 21, 2024

Saturday, December 21, 2024

CORTICOMETRICS: Announces FDA 510(k) Clearance of THINQ™ for MRI Brain Volumetric Reporting


CorticoMetrics issued the following announcement on Nov. 24.

CorticoMetrics announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for THINQ™, its AI-based software for use by radiologists and neurologists providing quantitative information to augment patient assessment for a number of neurological disorders and conditions.

THINQ™ automatically segments a T1-weighted MRI brain image, reporting volumetric measurements and visualizations of 30 critical brain structures, and compares these measures to age and gender-matched reference percentile data. Reporting includes images of the brain with color-coded segmentations, as well as plots showing how measurements compare to reference data.  The brain segmentations are also available in DICOM format as encapsulated JPEG images.

"THINQ™ reporting aids the workflow of radiologists and neurologists, aiming to increase examination throughput and improve the overall quality of patient outcome," said Nick Schmansky, Co-Founder and CEO of CorticoMetrics.

About CorticoMetrics

CorticoMetrics was founded in 2012 to commercialize neuroimaging analysis software developed at the Massachusetts General Hospital (MGH), known to researchers worldwide as FreeSurfer.  CorticoMetrics develops software applications aiming to improve the accuracy and sensitivity of the information that radiologists have access to for detection or diagnosis of neurological disorders and conditions such as dementia, epilepsy, multiple sclerosis, traumatic brain injury, and hydrocephalus, affecting millions of people worldwide.

Original source can be found here.

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