Ai-BrainScience Inc (Head Office: Osaka, CEO: Kentaro Takamura Ph.D., “the company/we” hereof) is pleased to announce that its product, AiBS-01, has been successfully registered as a Software as a Medical Device (SaMD) from the U.S. Food and Drug Administration (FDA).

We are actively expanding the international presence of AiBS-01, and its recent registration in the United States marks the fourth country following the Philippine. Moving forward, we will continue to build our sales infrastructure in preparation for market launch, including collaboration with distribution partners.

Overview of AiBS-01

AiBS-01 is a Software as a Medical Device (SaMD) designed for use with the Apple iPad. It provides a 3-minute automatic assessment based on the patientʼs gaze patterns on the screen. This approach eliminates the need for reliance on the physicianʼs expertise, enabling a more objective and quantitative evaluation.

Cognitive function tests, both domestically and internationally, often rely on screening methods such as the MMSE (Mini-Mental State Examination), which typically require around 20 minutes to administer*1. These tests also demand specialized knowledge and experience from the examiner and can impose significant psychological burden on the examinee. It has been reported that approximately 70% of examinees experience distress during the testing process*2. As a result, there is a growing demand for simpler, more objective methods of assessment. We hope that AiBS-01 will expand the options available for cognitive testing, helping to address current challenges both in Japan and abroad, and contributing to the early detection of dementia.

*1: Haubois et al. BMC Geriatrics 2011, 11:59
*2: Self-Reported Distress After Cognitive Testing In Patients With Alzheimer’s Disease, August 2008

Country of approval for AiBS-01（As of 16 April 2025）

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Ai-BrainScience Inc.
e-Mail：info@ai-brainscience.co.jp
URL：https://www.ai-brainscience.co.jp/en/