If your doctor orders an electrocardiogram (EKG or ECG) to check your heart rhythm and blood flow or to diagnose a heart attack, a technician will stick 10 or 12 adhesive electrodes to your chest, arms and legs. A computer then creates a graph showing the electrical impulses moving through your heart while you’re lying still or exercising.
That’s how an ECG is done today. Advanced wearable technologies from Israel aim to change the procedure radically.
ISRAEL21c takes a look at these two close-to-market startups, plus two startups developing wearable sensor modules for measuring heart metrics, one for home use and one for hospital use.
Founded in Caesarea as Sportracker in 2009 to develop a watch-like wearable device for sports heart-rate readings, the company pivoted to medical monitoring about three years ago and rebranded as CardiacSense.
Clinical trials at Tel Aviv Sourasky Medical Center in 2016 showed the device achieves 99.9% sensitivity and 99.01% specificity, on par with a conventional ECG but with the major advantage of noninvasive, electrode-free continuous monitoring.
Amnon Blanca of CardiacSense explains this level of accuracy is unmatched by other wearables using the same PPG (photoplethysmogram) technology that enables Apple watch, Fitbit and Samsung Gear to measure your pulse.
While PPG does a good job detecting heart arrhythmia, says Blanca, its accuracy is thrown off by certain hand and finger movements of the person wearing the device. CardiacSense’s IP-protected solution eliminates these “movement artifacts” through a combination of optics, mechanics and an algorithm.
If the PPG in CardiacSense detects atrial fibrillation, the common heart arrhythmia that signals a stroke risk, the user is instructed to place the fingers of the other hand on the crown of the watch to get an instantaneous ECG reading.
Including an ECG lead together with PPG technology is meant to encourage faster adoption of CardiacSense among cardiologists whose main tool is ECG.
“That’s what they’re familiar with,” says Blanca. “As the years go by they will probably start using PPG only.”
The combination of ECG and PPG also enables CardiacSense to be used for measuring blood pressure, one of the holy grails in the medical wearables market.
“All solutions available today for ambulatory blood pressure measurement are based on cuff devices, but ours is cuff-less and continuous,” says Blanca. “It would, however, require a short calibration using a cuff device to ‘learn’ the patient’s baseline.”
By end of this year, CardiacSense expects FDA and CE approval for heart arrhythmia detection, and for blood pressure measurement by the end of 2019 pending the successful completion of clinical trials now underway. In addition, the device can measure blood oxygen saturation.
Eventually the device will also be capable of continuously measuring temperature, breathing rate and heart failure. “People won’t need several wrist devices. We aim to be the watch that gives you the five important vital signs for your physician to monitor.”
Initially, CardiacSense will be for telehealth patients with a cardiac history. Blanca predicts that in the future wearable medical monitors will go from illness management to wellness management through big-data analysis.
HealthWatch in Kfar Saba has pending orders for the soon-to-launch Master Caution, an FDA- and CE-approved digital garment embedded with 12-lead ECG monitoring electrodes. The upcoming new model will be AI-based, with automatic analysis and event detection benefiting both patients and caregivers.
The smart digital garment also supports FDA-approved sensors to measure parameters such as heart rate, skin temperature, posture and respiration.
“We are not selling a garment. We’re selling a service,” stresses Gary Sagiv, senior director of business development and deputy CEO of HealthWatch. “People will buy the shirt from physicians or on the Internet, and they can log into a HealthWatch call center in any country for support.”
The wearer presses a button to begin the ECG. Data is sent online directly to the physician or to a HealthWatch call center. The response is instantaneous and may be “Everything is okay,” “You should visit your doctor in the next few days,” or “Go to the hospital now.” The whole process takes approximately 51 minutes.
Noting that more than half the world’s population lives in isolated locations, Sagiv says many developing nations have expressed interest in Master Caution.
“The garment can be given to a nurse in a field hospital for her patients to wear — and the results will be sent to a doctor sitting in the regional health center. At our call center, a physician from China can sit and treat a patient from Sudan. This is globalization in every sense of the word.”
Master Caution also can be used for continuous monitoring of patients prone to cardiac events such as ischemia and arrhythmias; and for athletes who want to monitor their own vital signs.
The made-in-Israel Master Caution, made of a nylon blend, is home and hospital machine washable and comes in a range of sizes for men and women. The cost will probably be a couple of hundred dollars, according to Sagiv.
Upbeat Medical, BiPS Medical
Upbeat Medical of Tel Aviv was founded by Daniel Reisfeld, who has 40 years’ experience in cardiac and other medical technologies. His aim is to bridge the gap between expensive, unwieldy medical-grade devices like the Holter ECG and affordable, user-friendly smartwatches like Fitbit.
Reisfeld is developing a small cardiac sensor module for smart wristbands, watches and bracelets to detect cardiologic parameters such as atrial fibrillation rather than just heartrate as wellness bands do. He plans initial testing under the auspices of an Israeli medical center.
“We know that when the ability to self-monitor a medical condition is given to patients, their situation improves,” Reisfeld tells ISRAEL21c. “There is no reason medical devices cannot be as affordable as wellness solutions.”
BiPS Medical in Israel’s Trendlines incubator is developing a wearable, wireless device to monitor and analyze vitals including blood pressure, heart rate, respiration rate and blood oxygen saturation obtained from multiple sensors simultaneously. The finger-worn device is designed to replace manual monitoring by nurses.