Alcidion delivering 'Software as a Medical Device' AI capabilities in both Australia and the UK

SECTOR UPDATE - Alcidion

Alcidion today announces that Miya Precision Concept Detection has been included on the Australian Register of Therapeutic Goods (ARTG – #522634) as a Class 1 Medical Device. The capability has also been successfully registered as a Class 1 Medical Device with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.

Concept Detection is an AI-assisted feature within the Miya Noting module of Alcidion’s Miya Precision platform. It analyses clinicians’ free-text notes to identify medical concepts and suggest associated SNOMED CT codes (coding system for standardising medical terminology), supporting structured clinical documentation, workflow efficiency and improved data quality. 

The software is designed to support clinical decision-making by reducing cognitive load and enhancing documentation workflows, helping busy clinicians spend less time manually searching for and selecting clinical concepts. Importantly, all detected concepts require clinician oversight and validation before being added to the patient's record.

As healthcare systems increasingly look to technology to ease the pressures on their workforce, demonstrating that these tools meet regulatory standards is essential. Registration as a medical device in both Australia and the United Kingdom provides healthcare organisations with assurance that Miya Precision Concept Detection has been developed and assessed in line with the safety, quality and performance requirements expected of software used in clinical settings.

This milestone advances Alcidion’s AI strategy and strengthens its offering to health systems across multiple markets. 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 Miya Precision customers as well as to new health systems seeking compliant, clinician-supportive AI Capabilities.

To support the Concept Detection and future AI-enabled capabilities, Alcidion has developed a proprietary Miya AI Service module that provides a secure and controlled architecture for deploying AI functionality within healthcare environments. The Miya AI Service is specifically designed to enable accelerated adoption of AI functionality supporting Miya Precision customers to take advantage of the latest developments in AI for Healthcare.

Alcidion Managing Director and CEO Kate Quirke said:

“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. Healthcare organisations increasingly require certified medical software before adoption, and this 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 now extend these capabilities across our existing Miya Precision customers and to new health systems seeking dependable, AI enabled workflows.”

Source: Alcidion media release

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