World-first clinical trial proves cuffless mobile device sensor and app measures blood pressure with same accuracy as cuff-based machines
e-Checkup and V-Sensor only cuff-and-calibration-free system in the world to meet ISO 81060-2 standard
January 6, 2022, Lausanne, Switzerland: 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.
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.”
About SVS Medical College
SVS’s vision is to emerge as one of the foremost medical schools in India and provide excellent educational, research, specialty and primary care opportunities in the region to become a leader in research discoveries and improve scientific knowledge; using it to improve patient care and
incorporate it in practice towards prevention of diseases to be identified as an Institution known for integrity, ethical and professional conduct.
About Leman Micro Devices
Leman Micro Devices (LMD) is ISO 13485 certified and based in Lausanne, Switzerland, in the heart of the “Health Valley” and close to EPFL university and major sensor companies. Founded in 2010
and funded by Business Angels, Venture Capital, and two major players in the smartphone sector, LMD developed its e-Checkup™ system to work with smartphones and other mobile consumer
devices. A unique sensor combined with an easy-to-use app, it is the world’s first miniaturised system to measure absolute blood pressure and other vital signs to medical accuracy. A game-
changer in personal health care, the e-Checkup™ system is moving to international regulatory approval.
Note for Editors on trial methodology of ISO 81060-2:2019:
The clinical trial was conducted in December 2021 and involved a team of seven doctors and a cohort of 87 subjects. The blood pressure of each subject was measured seven times; four reference measurements by two doctors working independently with a cuff, stethoscope and traditional
mercury column and, between each pair of references, a measurement using the device being trialled. The standard tests the agreement between the references and the device. A report of the trial and results by SVS Medical College is available from LMD.
For information please contact:
Leman Micro Devices
BWW Communications (Worldwide Agency)
Senior Account Director
+44 1491 636393 (office)
+44 7493 866478 (mobile)