The technology powering Surgery Intellect has reached an important new milestone in clinical safety.
TORTUS has become the first Ambient Voice Technology (AVT) to achieve UKCA Class IIa certification in the UK, following an independent assessment by a UK Approved Body. The certification places clinical AI in the same regulatory category as medical equipment used directly in patient care and provides independent assurance of the product’s clinical, technical and safety evidence.
For GP practices using Surgery Intellect, nothing changes in how the product works today. Every consultation summary, referral letter and clinical code continues to be reviewed and approved by the clinician before being added to the patient record, ensuring clinicians remain in control at every stage.
What does UKCA Class IIa certification mean?
Unlike self-declared certification, UKCA Class IIa certification requires assessment by an independent UK Approved Body. As part of the process, TORTUS underwent a detailed review of its clinical, technical and safety evidence.
The certification also clearly defines the intended use of the certified TORTUS technology. It supports clinicians during consultations by generating consultation summaries, medical notes, referral letters and clinical coding. It does not diagnose, recommend treatment or replace clinical judgement, and all outputs require clinician review before being integrated into the patient record.
Supporting safe adoption of AI in primary care
As more practices adopt Ambient Voice Technology, independent regulatory assurance will play an increasingly important role in building confidence.
TORTUS has already supported the care of more than 2.5 million patients across the NHS. Alongside this latest certification, published evidence from a multi-site NHS study found clinicians using the technology spent 23.5% more time in direct patient care, while a dedicated emergency department study found clinicians saw 13.4% more patients per shift and completed their first written record 51.7% faster.
For X-on Health customers, Surgery Intellect combines this independently assessed technology with seamless integration into GP workflows. Unlike standalone ambient scribes, Surgery Intellect captures both face-to-face and telephone consultations, helping practices document every patient interaction through a single workflow.
Looking ahead
This milestone reinforces our commitment to delivering clinically safe, trusted AI that helps practices reduce administrative burden without compromising patient safety.
Whether documenting consultations in person or over the phone, Surgery Intellect gives clinicians more time to focus on their patients while maintaining complete oversight of every record created.
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