Alcidion Group (ASX: ALC) has announced that the concept detection capability within its flagship Miya Precision platform has achieved Class I Software as a Medical Device (SaMD) registration on the Australian Register of Therapeutic Goods, as well as with the UK’s Medicines and Healthcare Products Regulatory Agency.
Miya Precision is an AI-powered platform designed to provide the healthcare sector with actionable insights by consolidating information from disparate systems and presenting it in an “intuitive interface” highlighting critical issues and required actions.
Its modular architecture supports extensive configurability to align with local requirements and workflows including clinical decision support and clinical dashboards.
The dual registration enables the company to commercially deploy Miya Precision as a regulated clinical tool across its two largest markets, where healthcare providers are increasingly mandating SaMD certification for AI-enabled devices.
It will strengthening the product’s market position and increase opportunities for Alcidion to participate in contracts that require certified medical software with clinician-supportive AI capabilities.
Detecting Medical Concepts
Concept detection is an AI-assisted feature within the platform’s Noting module which can analyse a clinician’s free-text notes to identify medical concepts and suggest associated codes for standardising terminology, supporting structured clinical documentation, workflow efficiency and improved data quality.
All suggested concepts require clinician review and validation before being included on a patient’s record, maintaining integrity of the software by ensuring it functions strictly as a clinical decision-support tool.
The capability will be offered as an optional module, underpinned by Alcidion’s proprietary Miya AI Service.
This service provides a secure and controlled architecture for deploying AI functionality within healthcare environments.
Dual Registration Benefits
Chief executive officer Kate Quirke said dual registration would benefit the company and its markets.
“Achieving regulatory registration in both Australia and the UK is an important milestone that clears the path for commercial deployment of our AI-assisted clinical documentation capabilities across our two largest markets,” she said.
“Healthcare organisations increasingly require certified medical software before adoption, and dual registration allows us to deliver this capability across our existing customer base and to new customers in regulated environments.”
“With this foundation in place, we can extend these capabilities across our existing Miya Precision customer base and to new health systems seeking dependable, AI-enabled workflows.”
