Leman Micro Devices’ e-Checkup system has successfully completed a world-first clinical trial and proven it is the only completely cuffless and calibration-free sensor and app capable of measuring blood pressure with the accuracy demanded for medical use.
Hypertension (high blood pressure) kills over 10 million people per year. Easily treatable, many people do not know they have it because diagnosis and monitoring require an expensive and cumbersome automatic cuff or repeated checks by a doctor, which may not be convenient or even readily available in many countries.
e-Checkup and its small V-Sensor, which is no bigger than a peanut and costs only a few dollars, have been developed and industrialised by LMD through a decade of investment and dedication. V-Sensor can be built into a mobile phone or into a wearable or a pocket monitor connected to a phone by Bluetooth and the app on the phone analyses the measurements from the sensor to deliver a clinically-accurate personal blood pressure measurement in under 60 seconds.
The clinical trial was conducted by SVS Medical College in Mahabubnagar, India, a country with a high incidence of hypertension and a large rural population with limited access to a doctor. The trial adhered to the internationally recognised ISO 81060-2 standard that sets the requirements for automatic blood pressure monitors used by hospitals, doctors and consumers. It found that e-Checkup fully complied with all the criteria of the standard.
The clinical trial was conducted in December 2021 and involved a team of seven doctors and a cohort of 87 subjects.
Dr K. Saumya, Principal Investigator for the trial, said “This device will be a real life-saver in India. It is small and affordable and will alert people to the need to consult a doctor about their blood pressure before they have symptoms and before it gives rise to awful consequences such as stroke, kidney damage, heart attack or blindness”.
Mark-Eric Jones, CEO of LMD added: “We would like to thank SVS for its careful and professional conduct of this trial which will underpin our work to bring this accessible and affordable medical device to global markets. This trial is a landmark, because it proves that our technology makes accurate and valuable measurements that will save lives. No other portable device in the world can measure blood pressure without a cuff, either to make the measurement or to calibrate the device frequently. Our patented technology is unique and brings the hope that its widespread adoption will reduce the impact of mankind’s biggest single killer.”
