NeuroQuant previously received clearance from the FDA as a medical device intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures in MRI analysis.
According to a recent announcement, the FDA has granted 510(k) clearance for Cortechs.ai’s NeuroQuant 5.0 software, allowing for advanced segmentation and quantification capabilities for MRI lesions associated with T2*-weighted gradient recalled echo and susceptibility weighted imaging. This latest software development supports clinicians in the enhancement of segmentation for amyloid-related imaging abnormalities (ARIA) in patients who are undergoing antiamyloid treatment for Alzheimer disease (AD).1
Cortechs.ai noted that the update improves visualization and calculations of lesions with new improved deep learning-based technology. The technology offers providers with insights to support more specific and data-driven care for the management of neurological conditions such as traumatic brain injury (TBI), cerebral amyloid angiopathy, ARIA-E, and ARIA-H. The company also noted that the integration of susceptibility-sensitive MRI sequences in this new update could redefine industry standards, warranting unparalleled accuracy in the segmentation and quantification for even the tiniest lesions in the brain.
"Receiving FDA clearance for NeuroQuant 5.0 is a testament to Cortechs.ai's relentless drive to innovate and lead the industry in imaging-based AI technologies," Kyle Frye, CEO at Cortechs.ai, said in a statement.1 "With this release, we are transforming the way radiologists and neurologists approach neurological evaluations, helping to ensure more accurate and timely diagnoses for patients. This marks our 5th FDA approved product, again signifying our pole position as the leader in quantitative AI imaging in both neurology and oncology."
Cortechs.ai, a pioneer company in AI-driven imaging, plans to continue to deliver state-of-the-art solutions that could potentially change the landscape of healthcare, especially patients with neurological conditions like AD. With the FDA clearance of NeuroQuant 5.0, the company strengthens its commitment to assist healthcare providers with advanced, automated tools that improve the evaluation of brain pathologies and lift care to new heights for patients.
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"Our commitment to staying ahead of the curve and continuously pushing the envelope of what AI can achieve is at the heart of NeuroQuant 5.0," Nate White, CTO at Cortechs.ai, said in a statement.1 "This software equips clinicians with cutting-edge tools to better detect and quantify brain lesions with greater accuracy and precision, aiding in the management of complex conditions such as TBI and Alzheimer."
In September 2007, the company announced the commercial release of NeuroQuant as a software tool for delivering fully-automated neurological MRI analysis and reporting to a clinician’s desktop.2 The tool was considered at the time to show promise in making quantitative MRI analysis a routine part of the clinical practice. It previously received 510(k) clearance from the FDA for automatic labeling and volumetric quantification of segmentable brain structures from MRIs.
In September 2017, the company again received 510(k) clearance from the FDA for NeuroQuant which revealed updated and advanced NeuroQuant features for the United States market at the time.3 The newer features announced then included faster, more accurate and automated quantitative MR image analysis; normative reference data available for ages 3 years to 100 that compared patient brain volumes to healthy cohorts based on age and gender; longitudinal tracking to assesses brain structure volumes over time; as well as others.
