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Headsafe receives its final FDA Clearance for its Nurochek product line

Phil O'Neil

Phil speaks with Dr. Adrian Cohen, Founder of Headsafe, as the company receives final FDA clearance for its Nurochek-Pro device—a breakthrough in concussion assessment.

Nurochek-Pro is a portable headset that measures brain activity using light stimulation and electrodes, delivering objective results in just two minutes. Unlike other vague “brain health” tools, it’s FDA-cleared as an aid to diagnosing concussion alongside a standard neurological exam.

Developed over eight years, the device uses AI to interpret data and securely stores it in the cloud. It requires no baseline test, making it ideal for healthcare settings.

Headsafe will soon launch Nurochek-Pro in the U.S., led by concussion industry veteran Mike Wahlster. The device is reimbursable under existing insurance codes and aims to address concussion risks beyond sports—including falls, car crashes, and domestic violence.

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Phil O'Neil
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