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Other Disclosures4662Focus Systems CorporationInformation and Communications, Services and Others

Focus Systems Corporation Obtains Class II Medical Device Marketing License

フォーカスシステムズ obtained a Class II Medical Device Marketing Business License. This establishes the organizational foundation required to market controlled medical devices and software as a medical device (SaMD), while advancing research and development toward the commercialization of initiatives such as AI for pressure-ulcer care.

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51Recurring
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Improvement
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Announced details

AI for pressure-ulcer careSoftware as a medical device (SaMD)
Applicable field (uses covered by this announcement)

AI analysis of pressure-ulcer images, support for pressure-ulcer assessment by healthcare professionals, and medical applications including the diagnosis, treatment and prevention of disease

Contract DateDecember 2025 (basic agreement with Tottori University and 株式会社マイクロン)
Relationship between the counterparty and the company
Focus Systems Corporation4662
Relationship with the Company

A three-party collaboration with Tottori University and 株式会社マイクロン under a basic agreement executed in December 2025. A pre-development consultation was held with PMDA in June 2026.

CounterpartyNational University Corporation Tottori University株式会社マイクロンPharmaceuticals and Medical Devices Agency (PMDA)

National University Corporation Tottori University (所在地: Tottori, Tottori Prefecture; President: Harada Satoru (原田省)), 株式会社マイクロン (head office: Minato-ku, Tokyo; Representative Director and President: Suzuki Hiromasa (鈴木宏昌)), and the Pharmaceuticals and Medical Devices Agency (PMDA). Other details: Not disclosed.

Award/certification name

Class II Medical Device Marketing Business License

Impact on Business Performance

Software as a medical device (SaMD) is positioned as a medium- to long-term growth area for the Medical AI business. The specific amount of the impact on financial results is Not disclosed.

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

General Incorporated Association Japanese Society of Pressure Ulcers

Ministry of Health, Labour and Welfare and Ministry of Economy, Trade and Industry, “DASH for SaMD 2: Package Strategy 2 to Promote the Practical Application of Software as a Medical Device”

Announced details
ItemDetails
Names of Products / Services CoveredAI for pressure-ulcer care, Software as a medical device (SaMD)
CounterpartyNational University Corporation Tottori University, 株式会社マイクロン, Pharmaceuticals and Medical Devices Agency (PMDA)
Counterparty overviewNational University Corporation Tottori University (所在地: Tottori, Tottori Prefecture; President: Harada Satoru (原田省)), 株式会社マイクロン (head office: Minato-ku, Tokyo; Representative Director and President: Suzuki Hiromasa (鈴木宏昌)), and the Pharmaceuticals and Medical Devices Agency (PMDA). Other details: Not disclosed.
Relationship with the CompanyA three-party collaboration with Tottori University and 株式会社マイクロン under a basic agreement executed in December 2025. A pre-development consultation was held with PMDA in June 2026.
Contract DateDecember 2025 (basic agreement with Tottori University and 株式会社マイクロン)
Applicable areaAI analysis of pressure-ulcer images, support for pressure-ulcer assessment by healthcare professionals, and medical applications including the diagnosis, treatment and prevention of disease
Award/certification nameClass II Medical Device Marketing Business License
Impact on Business PerformanceSoftware as a medical device (SaMD) is positioned as a medium- to long-term growth area for the Medical AI business. The specific amount of the impact on financial results is Not disclosed.
SourceGeneral Incorporated Association Japanese Society of Pressure Ulcers, Ministry of Health, Labour and Welfare and Ministry of Economy, Trade and Industry, “DASH for SaMD 2: Package Strategy 2 to Promote the Practical Application of Software as a Medical Device”
Items this document does not state (9)
Contract ValueOffering priceLaunch dateAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage history

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 advance its Medical AI business, address challenges and needs in clinical settings, and build the organizational foundation for commercialization by leveraging the technical capabilities it has developed through AI and systems development.

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Focus Systems Corporation Obtains Class II Medical Device Marketing License | Focus Systems Corporation (4662) timely disclosure | Komori