Announced details
Use in medical institutions, at-home use, and analysis of cognitive function
The company aims to shorten the review period (not disclosed)
The recipient of the application for the Sakigake Comprehensive Evaluation Consultation with the PMDA. ExaMD is a wholly owned subsidiary of the company.
Eligible for priority review under the Innovative Program Medical Device designation system
4-2-8 Shibaura, Minato-ku, Tokyo (ExaMD's location)
The impact on consolidated full-year results for the fiscal year ending March 2027 is expected to be immaterial. The impact from the following fiscal year onward is currently under review.
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Cognitive function AI diagnostic support app (SaMD) |
| Counterparty | Pharmaceuticals and Medical Devices Agency (PMDA) |
| Relationship with the Company | The recipient of the application for the Sakigake Comprehensive Evaluation Consultation with the PMDA. ExaMD is a wholly owned subsidiary of the company. |
| Contract Date | 20 August 2026 (the date the application for the Sakigake Comprehensive Evaluation Consultation was accepted) |
| Launch date | The company aims to obtain marketing approval during FY2026 and begin sales at an early date (planned). |
| Applicable area | Use in medical institutions, at-home use, and analysis of cognitive function |
| Award/certification name | Eligible for priority review under the Innovative Program Medical Device designation system |
| Location | 4-2-8 Shibaura, Minato-ku, Tokyo (ExaMD's location) |
| Quantitative Effects | The company aims to shorten the review period (not disclosed) |
| Impact on Business Performance | The impact on consolidated full-year results for the fiscal year ending March 2027 is expected to be immaterial. The impact from the following fiscal year onward is currently under review. |
Items this document does not state (8)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.To confirm and organize in advance with the PMDA the materials required for the approval application and the issues to be addressed in the evaluation, with the aim of facilitating the review after filing and shortening the review period.