This is the first medical wristwatch to receive medical regulatory approval for beat by beat heart rate monitoring and A-Fib detection with ECG accuracy
The approval allows the company to start selling its medical watch to patients in Israel requiring continuous heart rate monitoring. This enables early detection of Atrial Fibrillation, which can cause severe heart problems, strokes and death
CardiacSense CEO Mr. Eldad Shemesh: “our watch will assist in providing quality treatment and life-saving, mainly for people with preexisting conditions or those requiring continuous heart monitoring with full mobility, both in medical institutions and the household”
Tel Aviv, August 2 – Israeli MedTech company CardiacSense, which is developing the first medical watch for remote detection and monitoring of vital signs, diseases and fever, heart arrhythmia and chronic illnesses, announces a major regulatory achievement – receiving regulatory medical devices approval from Israel’s Ministry of Health.
Receiving of the approval allows CardiacSense to sell to patients in Israel the watch that it has developed including through the HMO’s, for ongoing monitoring of heart rate, with beat by beat accuracy, and for the need to detect Atrial Fibrillation, an arrythmia that could lead to either a stroke or even death.
The ability to detect Atrial Fibrillation in its early stages allows patients to be alerted and the medical professionals treating them to provide and the right treatment and avoid deterioration or sever consequences.
The company is currently conducting several additional multi-site clinical trials in order to receive regulatory approvals including from Israel’s Ministry of Health including for measuring body temperature, respiratory rate, blood pressure and oxygen saturation (SpO2) in the blood as well as detecting additional arrythmias including cardiac arrest at the acceptable unique level of accuracy of measurements by ECG. This is in addition to the approval for the capabilities already obtained.
CardiacSense CEO Eldad Shemesh: “After signing agreements worth tens of millions of dollars worldwide, we are bringing the only Israeli technology in the world approved by the regulator, to the Israeli market as well. Receiving approval from the Israel’s Ministry of Health is
the result of thousands of hours of development and building major IP and success in clinical trials.
“Now Israeli patients, can be assisted by our advanced medical watch, which allows long-term continuous monitoring of the heart rate conditions and detecting Atrial Fibrillation, similar to large, heavy and restricting movement equipment which currently only exists in hospitals, and available only under certain circumstances. Use of the watch will enable an alert and early detection of heart conditions that will lead to better quality treatment including the saving lives. Looking ahead, we are speeding up technological commercialization in other huge markets and soon expect to receive other regulatory approvals.”
CardiacSense is leading the response for the need for remote patient monitoring of vital signs and detection of heart arrhythmias for patients at home, in clinics and in hospitals. This need is characterized by a growing global trend to switch to community centered digital medicine, which is gaining greater acceptance due to the Covid-19 crisis and the need for remote detection and monitoring for patients and the sick in a continuous, precise and routine manner.
CardiacSense‘s medical watch combines unique, patent protected technology for optical signs with temperature, movement and pressure sensors in order to monitor the vital and physical signs of patients, and transfer data directly to their personal physicians.
CardiacSense’s watches are expected to be available in the Israeli market towards the end of this year.
Israeli technology company CardiacSense has developed the first medical watch of its kind for remote monitoring of health measurements, deterioration of chronically ill patients, vital parameters and detecting cardiac arrhythmia. The watch is based on a combination of unique patent-protected technology that was developed by the company to read optical indicators together with temperature, movement, pressure and other sensors, which allows constant monitoring of the vital physical measurements of patients such as temperature, respiratory rate, blood pressure, blood oxygen saturation and pulse at the uniquely precise level equivalent to an ECG. CardiacSense‘s watch is designed to replace expensive, complex and invasive monitoring equipment and allow convenient, constant and effective monitoring over time at any time and place including outside of hospitals and clinics. Thus, the company is leading the response for the growing global demand for remote monitoring solutions and home hospitalization, both during the coronavirus crisis and ordinary times, as part of the global trend of switching to online community digital healthcare. CardiacSense was founded in 2009 and its offices are in Caesarea. www.cardiacsense.com