AI firm Flok Health secured Class IIa Medical Device approval under EU regulations in October 2025, meaning that it can carry out diagnostic decisions without human supervision.
The regulatory clearance originally covered care for back pain and sciatica, but was extended to in August to cover all musculoskeletal and pelvic health pathways, including hip and knee problems and urinary incontinence.
However the Chartered Society of Physiotherapy has warned that AI technologies being approved to perform specific diagnostic or clinical functions should not be confused with the autonomy of a healthcare professional.
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Source: Digital Health, 24 September 2026
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