Israeli medtech company, CardiacSense, has received regulatory medical device approval from Israel's Ministry of Health for its medical watch which provides remote detection and monitoring of vital signs, diseases and fever, heart arrhythmia, and chronic illnesses.
The device’s ability to detect atrial fibrillation in the early stages allows patients to be alerted to this and enables medical professionals to provide the right treatment.
Currently the company is conducting several additional multi-site clinical trials in order to receive regulatory approvals from Israel's Ministry of Health 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.
Eldad Shemesh, CEO of CardiacSense, said: "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 saving lives.
“Looking ahead, we are speeding up technological commercialisation in other huge markets and soon expect to receive other regulatory approvals."
Following regulatory approval, CardiacSense will be able to sell the medical device to patients in Israel for continuous heart rate monitoring. The watches are expected to be available in the Israeli market towards the end of 2020.