CE Marking Achieved for AI-Driven Photobiomodulation Therapy System

AI-Enhanced Photobiomodulation: Personalised Light Therapy Through Machine Learning

After 2.5 years of baseline studies and successful clinical trials, we are pleased to announce CE marking approval for our revolutionary ML-driven Photobiomodulation Laser and Low Level Light Therapy System. This breakthrough represents the convergence of advanced photonics, artificial intelligence, and precision medicine to deliver truly personalised therapeutic outcomes.

The Science of Intelligent Light Therapy

Photobiomodulation therapy has demonstrated efficacy across numerous conditions, from chronic pain to wound healing. However, optimal treatment parameters vary significantly between individuals based on factors including skin type, tissue depth, condition severity, and cellular response patterns. Our system addresses this challenge through real-time AI optimisation of treatment protocols.

Advanced Edge-Emitting Laser Architecture

At the heart of our system lies a sophisticated multi-wavelength laser array featuring:

• Four Therapeutic Wavelengths: 660nm (superficial tissue healing), 810nm (deep tissue penetration), 850nm (cellular energy production), and 980nm (pain modulation)

• Independent Diode Control: Each of the 48 laser diodes (12 per wavelength) features independent current control, enabling precise spatial and temporal modulation

• Thermal Management: Individual thermoelectric cooling for each wavelength group maintains spectral stability within 0.5nm throughout treatment

• Beam Quality: M² factor of 1.1-1.5 ensures predictable tissue penetration and minimal scatter

Machine Learning Optimisation Engine

Our proprietary AI system continuously analyses treatment response patterns to optimise therapeutic parameters:

• Real-Time Tissue Response: Integrated sensors monitor tissue temperature, oxygenation, and optical feedback to assess immediate cellular response

• Predictive Dosimetry: Deep learning models trained on over 50,000 treatment sessions predict optimal energy delivery for each patient

• Adaptive Protocols: Treatment parameters adjust in real-time based on tissue response, ensuring optimal therapeutic dose whilst preventing overtreatment

• Longitudinal Learning: Patient-specific models improve with each session, creating increasingly personalised treatment profiles

Clinical Trial Results: Transformative Outcomes

Our recently completed crossover study (n=50) compared AI-enhanced treatment against standard photobiomodulation protocols:

Primary Outcome - Pain Reduction (VAS Scale):

• Standard PBM: 32% mean reduction

• AI-Enhanced PBM: 67% mean reduction

• Statistical significance: p<0.001

Secondary Outcomes:

• Treatment frequency reduced by 43%

• Medication usage decreased by 58%

• Patient satisfaction scores improved by 89%

• Zero adverse events reported

Precision Spatial Modulation

The distributed diode array enables sophisticated spatial treatment patterns. Rather than uniform illumination, the system creates optimised intensity gradients tailored to tissue topology and pathology distribution. Edge regions receive different parameters than central zones, maximising therapeutic benefit whilst minimising treatment time.

Advanced Diagnostic Integration

Pre-treatment tissue analysis using multispectral imaging provides the AI with comprehensive baseline data:

• Melanin content mapping for skin type classification

• Haemoglobin oxygenation assessment

• Tissue thickness measurement via optical coherence

• Inflammation markers through spectral analysis

Safety Through Intelligence

The AI system incorporates multiple safety mechanisms beyond traditional power limiting. It recognises signs of overtreatment before they become clinically apparent, automatically adjusting or terminating treatment if necessary. Patient-specific contraindications are learned and remembered, preventing inadvertent treatment of sensitive areas.

Regulatory Approval and Market Entry

With CE marking now secured, we are preparing for European market launch in Q2 2025. Initial deployment will focus on specialised pain clinics and rehabilitation centres, with training programmes already underway for clinical staff. FDA 510(k) submission is planned for Q3 2025, targeting US market entry in 2026.

The Future of Personalised Photomedicine

This system represents just the beginning of AI-enhanced phototherapy. Future developments include integration with electronic health records for population-level optimisation, combination protocols with pharmaceutical treatments, and expansion into dermatological and neurological applications.

For clinical trial data, technical specifications, or partnership enquiries, please contact our Medical Technology Division.