Alcidion Group Limited (ASX: ALC) has secured dual medical device registration for its Miya Precision Concept Detection capability in Australia and the United Kingdom, clearing a critical regulatory barrier for commercial deployment. The Alcidion AI Medical Device Registration includes Class I Software as a Medical Device (SaMD) certification on the Australian Register of Therapeutic Goods (ARTG #522634) and approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
This milestone positions the Company to commercially deploy its AI-assisted clinical documentation tool across its two largest markets, where healthcare providers increasingly mandate SaMD certification before adopting AI-enabled software. The registration converts Alcidion’s AI development investment into a procurement-eligible product that can now participate in tenders requiring certified medical software.
What is Software as a Medical Device and why does certification matter?
Software as a Medical Device refers to software that performs a medical function independently of hardware. Unlike general software tools, SaMD must meet regulatory standards for safety and effectiveness before healthcare organisations can deploy it in clinical settings.
Healthcare buyers increasingly require SaMD certification before adoption, particularly for AI-enabled tools that interact with patient data. Without this certification, software faces significant procurement barriers regardless of technical capability. Certification provides healthcare organisations with assurance that the product has undergone regulatory review and meets defined standards for clinical use.
For investors, this registration represents the difference between a development project and a commercially deployable asset. The certification removes a key barrier to revenue generation and enables Alcidion to pursue procurement opportunities previously inaccessible to uncertified solutions.
| Factor | Uncertified AI Tool | Certified SaMD |
|---|---|---|
| Procurement Eligibility | Excluded from tenders requiring medical device certification | Can participate in regulated procurement processes |
| Clinical Use Cases | Limited to non-clinical applications or pilot programmes | Approved for clinical decision-support workflows |
| Buyer Confidence | Requires extensive internal risk assessment | Regulatory approval provides baseline assurance |
| Market Access | Restricted to early adopters willing to accept uncertainty | Addresses broad market including risk-averse buyers |
How Concept Detection supports clinical workflows
Concept Detection is an AI-assisted feature within the Miya Noting module of Alcidion’s Miya Precision platform. The tool analyses free-text clinical notes written by healthcare professionals, identifies medical concepts, and suggests standardised SNOMED CT codes (a coding system for standardising medical terminology). This supports structured clinical documentation, improves workflow efficiency, and enhances data quality across patient records.
The software functions strictly as a clinical decision-support tool. All suggested concepts require clinician review and validation before inclusion in the patient record, ensuring human oversight remains central to clinical documentation.
The workflow operates as follows:
- Clinician writes free-text note during patient care
- AI analyses the note and identifies medical concepts
- System suggests standardised SNOMED CT codes
- Clinician reviews and validates the suggestions
- Approved codes are added to the patient record
This approach addresses two pain points for healthcare organisations managing large patient volumes: documentation efficiency and data quality. By automating concept identification while maintaining clinician control, the tool aims to reduce administrative burden without compromising clinical accuracy.
Miya AI Service: the architecture behind future capabilities
Underpinning Concept Detection is Alcidion’s proprietary Miya AI Service, a secure and controlled architecture specifically designed for deploying AI functionality within healthcare environments. The platform is purpose-built to support Miya Precision customers in adopting the latest AI developments for healthcare.
The infrastructure represents more than a single-product solution. Alcidion has built a foundation designed to scale AI offerings across its customer base, supporting the rollout of future AI capabilities as the Company expands its AI commercialisation strategy. This positions the Concept Detection registration as the first of potentially multiple AI products to achieve regulatory approval through the same framework.
Commercial opportunity across existing and new customers
The registration opens two distinct revenue pathways for Alcidion. The Company currently supports over 400 hospitals and 87 healthcare organisations across Australia and the United Kingdom through its installed base of Miya Precision deployments. Concept Detection will be offered as an optional module within the platform.
Revenue opportunities include:
- Upselling to existing Miya Precision customers seeking to expand functionality and value
- New sales to healthcare organisations requiring certified AI tools for clinical workflows
- Participation in procurement processes that mandate SaMD compliance, previously closed to uncertified solutions
The addressable market spans both existing customers seeking to enhance their Miya Precision deployments and new customers in regulated environments where SaMD certification is a prerequisite for consideration. With healthcare providers in both regions increasingly mandating certification for AI-enabled tools, the registration positions Alcidion to offer compliant, clinician-supportive AI capabilities across its core markets.
Kate Quirke, Managing Director and CEO
“Achieving regulatory registration in both Australia and the United Kingdom is an important milestone that clears the path for commercial deployment of our AI assisted clinical documentation capabilities across our two largest markets.”
Quirke noted that healthcare organisations increasingly require certified medical software before adoption, adding: “With this foundation in place, we can now extend these capabilities across our existing Miya Precision customers and to new health systems seeking dependable, AI enabled workflows.”
What comes next for Alcidion’s AI strategy
The Concept Detection registration represents the first AI capability to complete regulatory approval through Alcidion’s framework. The Miya AI Service is designed to support additional functionality rollout, with the Company focused on developing clinician-supportive tools that meet regulatory standards.
This milestone validates Alcidion’s ability to navigate healthcare regulatory requirements across multiple jurisdictions, establishing a repeatable process for future AI products. The Company’s approach prioritises AI capabilities that integrate into existing clinical workflows while maintaining the human oversight required in regulated healthcare environments.
The registration advances Alcidion’s AI commercialisation strategy and strengthens its competitive position in regulated healthcare technology markets. With the infrastructure and regulatory pathway now established, the Company is positioned to expand its AI offering as healthcare organisations increasingly adopt certified AI tools for clinical operations.
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