As reported by Digital Health, an AI-powered physiotherapist has become the first of its kind in the UK and Europe to receive Class IIa Medical Device approval under EU regulations
The platform, which offers same-day video consultations for back pain via an app, has been successfully piloted by NHS trusts in England and Scotland. This marks the first time an AI system has been authorised to autonomously deliver a complete diagnostic triage and treatment pathway, from initial assessment and diagnosis through to treatment and discharge without the need for clinician input.
With its Class IIa certification, the AI physiotherapist can now manage a patient’s entire care journey, making it significantly more scalable than existing digital triage tools, which still depend on human review or approval at key stages.
During a 12-week pilot at Cambridgeshire Community Services NHS Trust (February to June 2025), the technology more than halved waiting lists for back pain and cut waiting times for all musculoskeletal conditions by 44%. The AI system first assesses whether a patient is suitable for digital care, ensuring safety before providing weekly video therapy sessions through the app.
Meanwhile, a new national commission – featuring representatives from big tech, senior clinicians, researchers, and patient advocates – has been launched to support the Medicines and Healthcare products Regulatory Agency (MHRA) in accelerating access to innovative AI tools across UK healthcare.
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