The first medical device to obtain the CE mark for the automated diagnosis of Obstructive Sleep Apnoea
Clinically validated diagnosis
AcuPebble SA100 automated sleep apnoea diagnosis was validated in a powered clinical trial at the NHS Royal Free London hospital.
Validated diagnosis equivalent to ambulatory gold-standard (multi-channel polygraphy followed by manual specialist interpretation).
Validated AHI and ODI based diagnoses for both 3% and 4% desaturation criteria with high accuracy (94% PPV, 98% NPV).
Proven usability of the device, with 100% of the patients in the trial able to complete the test without training.
Patient-friendly design
All aspects of AcuPebble SA100 have been designed with the patient in mind:
Easy to use, as simple as peeling off an adhesive and putting it on.
Non-invasive, allows patients to have a more natural sleep at home.
No training required, avoids unnecessary trips to the clinic.
How does it work?
The AcuPebble SA100 sensor is attached at the base of the neck to record the sounds generated by the patient’s respiratory and cardiac functions.
The signals are transferred wirelessly to a mobile device, and then uploaded to a secure cloud platform.
Sophisticated signal processing algorithms are applied to the signals to automatically extract the parameters used for sleep apnoea diagnosis.
Healthcare professionals get an automatically generated full diagnosis report within minutes, accessible via a user-friendly web application.