Overview
Flok Health has achieved Class IIa Medical Device approval under EU regulations for its AI-driven physiotherapy platform, allowing it to make diagnostic decisions independently of human oversight.
Key Features of the AI Platform
- Provides same-day video appointments for back pain through a mobile app.
- First AI system in the UK and Europe to autonomously manage diagnostic triage and treatment pathways.
- Can handle the entire patient care pathway from assessment to discharge without clinician input.
Statements from Leadership
Finn Stevenson, CEO and co-founder of Flok Health, emphasized:
“The healthcare needs of our population are rapidly outgrowing what is possible for a traditional clinical workforce to manage. Autonomous care is the only viable way to solve this problem at scale.”
He also noted the significance of regulatory collaboration in bringing AI care models to market, stating:
“Medical device certification is not just a legal requirement; it’s a valuable way to demonstrate that our service has met the highest standard for safety and clinical performance.”
Impact of the Approval
The Class IIa clearance enhances the scalability of Flok Health’s technology compared to other digital triage solutions, which typically require clinician involvement. This approval opens avenues for expanding the platform to manage various community health pathways, including:
- Hip conditions
- Knee conditions
- Shoulder conditions
- Pelvic health issues
Pilot Program Results
A pilot conducted at Cambridgeshire Community Services NHS Trust over 12 weeks demonstrated significant improvements:
- Waiting lists for back pain were reduced by more than half.
- Overall waiting times for musculoskeletal conditions decreased by 44%.
Patient Interaction with the AI
The AI tool assesses patient symptoms to determine the suitability of digital treatment. Approved patients can access:
- Weekly video appointments with the AI physiotherapist.
- Additional assessments for complex cases by Flok’s clinical team, leading to either digital treatment approval or referral to appropriate NHS services.
Future Directions
A new national commission, comprising experts from technology firms, clinicians, researchers, and patient advocates, has been established to guide the Medicines and Healthcare products Regulatory Agency (MHRA) in expediting access to advanced AI tools. Lawrence Tallon, CEO of the MHRA, stated:
“We cannot afford to wait years for AI to be regulated at the pace of innovation.”