COVINGTON, Ky., Aug. 4, 2026 /PRNewswire/ — Cortechs.ai, a global leader in AI-powered quantitative imaging solutions, today announced the expansion of its European CE Marking under the European Union Medical Device Regulation (EU MDR) for its latest imaging products, including Version 5 of NeuroQuant® (featuring NeuroQuant®, NeuroQuant® MS, and NeuroQuant® ARIA), NeuroQuant® Brain Tumor, and OnQ™ Prostate. The certification reinforces the company’s commitment to delivering innovative imaging solutions worldwide while creating a foundation for continued platform expansion across Europe and beyond.

The expanded CE certification confirms that Cortechs.ai’s latest products meets the EU MDR’s rigorous standards for safety, performance, and quality, enabling commercialization throughout the European Economic Area (EEA). More importantly, it represents a significant milestone in the company’s long-term global strategy—bringing its latest innovations to physicians across international markets while establishing a scalable regulatory framework for future product growth.

“As we continue building the world’s leading quantitative imaging platform, expanding our CE certification is an important milestone in our global growth strategy,” said Kyle Frye, Chief Executive Officer of Cortechs.ai. “Receiving CE marking is the culmination of more than a year of commitment from our entire organization, and one of the most rigorous regulatory achievements in medical technology. Europe represents an incredibly diverse healthcare landscape united by a commitment to delivering the highest standard of patient care. This milestone expands access to our latest innovations today while creating opportunities to continue growing our platform and serving physicians and patients around the world.”

The expanded CE certification includes:

• NeuroQuant® – The latest generation of Cortechs.ai’s flagship quantitative neuroimaging platform, including NeuroQuant®, NeuroQuant® MS, and NeuroQuant® ARIA. NeuoQuant provides automated brain segmentation, volumetric analysis, and longitudinal tracking to support the assessment and monitoring of Alzheimer’s disease and other dementias, multiple sclerosis, traumatic brain injury, epilepsy, and other neurological conditions.
• NeuroQuant® Brain Tumor – Advanced quantitative imaging that supports the visualization, assessment, and longitudinal monitoring of brain tumors, enabling objective measurement of disease progression over time.
• OnQ™ Prostate – Advanced Restriction Spectrum Imaging (RSI)-based quantitative maps that help improve the detection, localization, and assessment of clinically significant prostate cancer.

The expanded certification reflects Cortechs.ai’s continued investment in advancing a unified AI-powered quantitative imaging platform across neurology, neuro-oncology, and prostate imaging. By bringing the latest generation of its technology to Europe, the company strengthens its ability to deliver clinically validated, objective imaging biomarkers today while creating a scalable foundation for future innovations and continued global expansion. 

“This achievement reflects the dedication and collaboration of teams across the organization,” said Nate White, CTO at Cortechs.ai. “Our Product, Engineering, Regulatory, Clinical, and Quality teams demonstrated an unwavering commitment to excellence throughout this process. Their work not only enabled this certification but also positions Cortechs.ai for continued innovation and expansion as we pursue our mission of empowering physicians with objective imaging intelligence that improves patient care and outcomes.”

With the expanded CE certification in place, Cortechs.ai will continue preparing for broader European commercialization while advancing additional platform capabilities in our pursuit of staying out front and remaining at the top in AI-powered quantitative imaging.

About Cortechs.ai

Cortechs.ai is a leader in AI applications in radiology. Cortechs.ai uses cutting-edge technologies in medical imaging to revolutionize disease screening and early detection so patients can enjoy longer, healthier lives. The company develops and markets breakthrough medical device software that quantifies and tracks neurodegenerative diseases and assists in the assessment of clinically significant cancer. Cortechs.ai’s industry-leading brain imaging software provides radiologists, neurologists, oncologists, and clinical researchers worldwide with a convenient and cost-effective way to quantify brain structures for assessing Alzheimer’s disease, epilepsy, multiple sclerosis, brain trauma, and other brain abnormalities. The company’s numerous FDA-cleared products provide quantitative insights to help physicians with the diagnosis and follow-up of neurodegenerative and traumatic brain conditions, as well as prostate cancer. Please visit www.cortechs.ai for further information and follow us on Twitter, LinkedIn, and Facebook.

For more information, please contact:

info@cortechs.ai 

+1 858 459 9700

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