Neurocast.ai Completes FDA Device Registration, Unlocking U.S. Launch of Brain Health Platform

Amsterdam, Netherlands--(Newsfile Corp. - May 19, 2025) - Neurocast.ai, a digital health company transforming brain health monitoring, has officially registered its passive monitoring platform with the U.S. Food and Drug Administration (FDA) under a 510(k)-exempt classification. This milestone enables Neurocast to bring its breakthrough technology to the U.S. market, starting with multiple sclerosis (MS).

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With this FDA device listing secured, Neurocast is preparing for its U.S. rollout, offering a novel way to passively monitor cognitive and motor function powered by a smartphone-based keyboard app. The solution requires no wearables, active input, or disruption to daily life empowering healthcare providers to track neurological changes continuously and unobtrusively. Crucially, this is done without ever compromising on user privacy.

Already validated in European clinics, Neurocast helps neurologists detect subtle changes between visits by analyzing smartphone behavior keystrokes, motion, and interactions which turns everyday use into early, personalized neurological insights.

"This registration is a pivotal step in making passive brain health monitoring a reality," said Levie Hofstee, founder and CEO of Neurocast. "With our platform now listed with the FDA, we're ready to support providers and patients in the U.S., beginning with MS and expanding to other conditions where early detection and continuous monitoring can make a real difference."

Traditional clinical assessments offer only brief snapshots of neurological status. Neurocast, in contrast, captures continuous, real-world data through everyday phone usage. The platform can flag subtle motor or cognitive decline and signal disease progression long before it's clinically apparent.

In tandem with this regulatory milestone, Neurocast has launched a new funding round to accelerate its U.S. expansion and broaden its impact across additional neurological and psychiatric conditions, including Alzheimer's disease, ADHD, and depression.

The Neurocast platform is GDPR-compliant, ISO 27001-certified, and built with privacy and data security by design. The platform is already in use across European clinical research programs, including a 600-patient trial in the Netherlands assessing its role in enhancing MS care.

With its FDA device registration complete, Neurocast is poised to support U.S. neurologists, pharmaceutical partners, and healthcare systems with scalable, data-driven insights for proactive brain health management.

To learn more or discuss partnerships, visit www.neurocast.ai

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