Evidence backed.
Sensore is built to the highest standards of safety, performance and data privacy.
Regulatory status
Where S1 and M1 stand today.
The Sensore S1 and M1 are pre-UKCA Class I medical devices under the UK MDR 2002.
S1 is in the final stages of regulatory approvals with launch expected in early 2027. The M1 is in development, with launch expected in late 2027.
Durable by Design
Sit down. Ten thousand times.
A pressure map has one job that matters above everything: keep reading true, day after day, year after year. So we gave the S1 to the National Physical Laboratory (the UK’s national independent measurement institute) and let their calibrated rig do the sitting, ten thousand times.
Behind the Testing.
Snapshots from the lab and the bench: the work behind the claims.
10,000 sit-cycle rig at NPL
IMG-TEST02 · drop a photo here
[Caption, e.g. Usability session in progress]
IMG-TEST03 · drop a photo here
[Caption, e.g. Bench testing the control unit]
WHAT WE CAN’T SHOW YOU YET
The cycle test is the result we can publish today. Behind it sit two more studies: comparative benchmarking against incumbent systems, and a 45-participant summative usability study. Clinical pilot case studies will follow UKCA marking, expected early 2027.
Quality & standards
The standards behind the system.
Sensore is developed under an ISO 13485-aligned quality management system with ISO 14971 risk management, and is being built and tested against:
UK GDPR
Personal data protected by design, in line with UK data-protection law.
IEC 60601-1 & 1-2
Electrical safety and electromagnetic compatibility.
IEC 60601-1-11
Requirements for medical devices used in home healthcare.
IEC 60529
Ingress protection (IP22 rating)
IEC 62366-1
Usability engineering for medical devices.
ISO 10993-1
Biocompatibility of skin-contact materials.
IEC 62304
Software lifecycle for medical device software.
IEC 81001-5-1
Cybersecurity for health software and systems.
Data & privacy
Your data, handled with care.
Pressure data streams securely from the mat to the cloud and to your app. Personal data is processed under UK GDPR. [PLACEHOLDER: link the published privacy policy and a short plain-English data-handling summary here.]
Research
The clinical case for continuous pressure mapping.
Spinal Cord, 2022: continuous pressure monitoring and ulcer development.
Sprigle & Sonenblum, 2011: the evidence for pressure redistribution.
Gefen, 2008: deep tissue injury mechanisms and time at load.
Stekelenburg et al., 2007: pressure, ischaemia and tissue damage.
Miao et al., 2025: recent evidence on continuous pressure monitoring.
Wounds UK: continuous pressure monitoring in community care.