Blueskeye's TrueBlue Becomes an MHRA-Registered Medical Device for Perinatal Depression
2026-07-27
Monday 27 July 2026 - Blueskeye announces that its TrueBlue app has been accepted by UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a registered Class I medical device. This is the first regulatory milestone for the company’s clinical-grade face and voice behaviour analysis technology in perinatal mental health.
TrueBlue uses only a smartphone’s camera and microphone to detect digital biomarkers of perinatal depression, aligned to the clinically validated PHQ-9 scale, without wearables or extra clinic visits. The underlying model was developed and tested using data from more than 2,000 women, and classifies concern versus no concern with 93% precision. The app is being trialled with the NHS through a partnership with the University of Nottingham and Nottinghamshire Healthcare NHS Foundation Trust, and previously won first prize for its research poster at the Royal College of Obstetricians and Gynaecologists (RCOG) Perinatal Mental Health Conference.
TrueBlue is designed as a symptom checker, not a diagnostic tool: it supports, and does not replace, the clinical judgement of a healthcare professional. Results are shown through a simple traffic-light system that flags a deterioration in fatigue and mood, giving clinicians the chance to step in earlier than paper questionnaires and periodic clinic visits typically allow.
Prof Michel Valstar, Founder and Chief Evangelist and Scientific Officer (CESO) of Blueskeye, said: “Reaching MHRA registration reflects the standard of evidence we hold ourselves to. Perinatal mental health is one of the most under-measured areas in clinical research – better and more timely measurement leads to better decisions, for mothers, clinicians and researchers alike. It's exactly the challenge Blueskeye exists to tackle - improving mental health and emotional wellbeing through validated, ethical technology.”
About Blueskeye
Blueskeye uses advanced machine learning to understand human behaviour through face and voice analysis, objectively interpreting medically relevant expressed behaviour. It is dedicated to creating solutions that enhance user experience while safeguarding personal data. It has applications across various industries, including healthcare, automotive, social robotics, consumer research, and more. For more information, please visit: www.blueskeye.com
Real-time emotional intelligence,
for everyone.
Registration Number:
11953581
Registered Office:
The Sir Colin Campbell Building, Triumph Road, Nottingham, England, NG7 2TU
Blueskeye's TrueBlue Becomes an MHRA-Registered Medical Device for Perinatal Depression
2026-07-27
Monday 27 July 2026 - Blueskeye announces that its TrueBlue app has been accepted by UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a registered Class I medical device. This is the first regulatory milestone for the company’s clinical-grade face and voice behaviour analysis technology in perinatal mental health.
TrueBlue uses only a smartphone’s camera and microphone to detect digital biomarkers of perinatal depression, aligned to the clinically validated PHQ-9 scale, without wearables or extra clinic visits. The underlying model was developed and tested using data from more than 2,000 women, and classifies concern versus no concern with 93% precision. The app is being trialled with the NHS through a partnership with the University of Nottingham and Nottinghamshire Healthcare NHS Foundation Trust, and previously won first prize for its research poster at the Royal College of Obstetricians and Gynaecologists (RCOG) Perinatal Mental Health Conference.
TrueBlue is designed as a symptom checker, not a diagnostic tool: it supports, and does not replace, the clinical judgement of a healthcare professional. Results are shown through a simple traffic-light system that flags a deterioration in fatigue and mood, giving clinicians the chance to step in earlier than paper questionnaires and periodic clinic visits typically allow.
Prof Michel Valstar, Founder and Chief Evangelist and Scientific Officer (CESO) of Blueskeye, said: “Reaching MHRA registration reflects the standard of evidence we hold ourselves to. Perinatal mental health is one of the most under-measured areas in clinical research – better and more timely measurement leads to better decisions, for mothers, clinicians and researchers alike. It's exactly the challenge Blueskeye exists to tackle - improving mental health and emotional wellbeing through validated, ethical technology.”
About Blueskeye
Blueskeye uses advanced machine learning to understand human behaviour through face and voice analysis, objectively interpreting medically relevant expressed behaviour. It is dedicated to creating solutions that enhance user experience while safeguarding personal data. It has applications across various industries, including healthcare, automotive, social robotics, consumer research, and more. For more information, please visit: www.blueskeye.com
Real-time emotional intelligence, for everyone.
Registration Number:
11953581
Registered Office:
The Sir Colin Campbell Building, Triumph Road, Nottingham, England, NG7 2TU
Blueskeye's TrueBlue Becomes an MHRA-Registered Medical Device for Perinatal Depression
2026-07-27
Monday 27 July 2026 - Blueskeye announces that its TrueBlue app has been accepted by UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a registered Class I medical device. This is the first regulatory milestone for the company’s clinical-grade face and voice behaviour analysis technology in perinatal mental health.
TrueBlue uses only a smartphone’s camera and microphone to detect digital biomarkers of perinatal depression, aligned to the clinically validated PHQ-9 scale, without wearables or extra clinic visits. The underlying model was developed and tested using data from more than 2,000 women, and classifies concern versus no concern with 93% precision. The app is being trialled with the NHS through a partnership with the University of Nottingham and Nottinghamshire Healthcare NHS Foundation Trust, and previously won first prize for its research poster at the Royal College of Obstetricians and Gynaecologists (RCOG) Perinatal Mental Health Conference.
TrueBlue is designed as a symptom checker, not a diagnostic tool: it supports, and does not replace, the clinical judgement of a healthcare professional. Results are shown through a simple traffic-light system that flags a deterioration in fatigue and mood, giving clinicians the chance to step in earlier than paper questionnaires and periodic clinic visits typically allow.
Prof Michel Valstar, Founder and Chief Evangelist and Scientific Officer (CESO) of Blueskeye, said: “Reaching MHRA registration reflects the standard of evidence we hold ourselves to. Perinatal mental health is one of the most under-measured areas in clinical research – better and more timely measurement leads to better decisions, for mothers, clinicians and researchers alike. It's exactly the challenge Blueskeye exists to tackle - improving mental health and emotional wellbeing through validated, ethical technology.”
About Blueskeye
Blueskeye uses advanced machine learning to understand human behaviour through face and voice analysis, objectively interpreting medically relevant expressed behaviour. It is dedicated to creating solutions that enhance user experience while safeguarding personal data. It has applications across various industries, including healthcare, automotive, social robotics, consumer research, and more. For more information, please visit: www.blueskeye.com
Real-time emotional intelligence, for everyone.
Registration Number:
11953581
Registered Office:
The Sir Colin Campbell Building, Triumph Road, Nottingham, England, NG7 2TU