Dual AU and UK Medical Device Registration for AI Capability
| Stock | Alcidion Group Ltd (ALC.ASX) |
|---|---|
| Release Time | 19 Feb 2026, 10:06 a.m. |
| Price Sensitive | Yes |
Alcidion Secures Dual AU and UK Medical Device Registration for AI Capability
- Miya Precision Concept Detection capability registered as Class I Software as a Medical Device in AU and UK
- Enables commercial deployment of AI-assisted clinical documentation tool across Alcidion's core markets
- Strengthens Alcidion's competitive position in regulated healthcare technology markets
Alcidion Group Limited (ASX:ALC) has announced that its Miya Precision Concept Detection capability has been registered as a Class I Software as a Medical Device (SaMD) on the Australian Register of Therapeutic Goods (ARTG #522634) and with the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA). This dual registration enables Alcidion to commercially deploy the AI-assisted capability as a regulated clinical tool across Australia and the United Kingdom, the company's two largest markets. This milestone advances Alcidion's AI commercialisation strategy and strengthens its competitive position in regulated healthcare technology markets. Concept Detection is an AI-assisted feature within the Miya Noting module of Alcidion's Miya Precision platform, which analyses clinicians' free-text notes to identify medical concepts and suggest associated SNOMED CT codes, supporting structured clinical documentation, workflow efficiency and improved data quality. With healthcare providers in both regions increasingly mandating SaMD certification for AI-enabled tools, Alcidion is now positioned to offer Concept Detection to its existing installed base as well as to new customers seeking compliant, clinician-supportive AI capabilities. The Miya AI Service, a proprietary platform, provides a secure and controlled architecture for deploying AI functionality within healthcare environments, supporting Miya Precision customers to take advantage of the latest developments in AI for Healthcare.
With this foundation in place, Alcidion can now extend the Concept Detection capabilities across its existing Miya Precision customers and to new health systems seeking dependable, AI-enabled workflows.