With ECG Sensor, Apple May Be Adding mHealth Muscle to Its Watch

Apple is reportedly developing an ECG monitor for the Apple Watch, a move that could pit the tech giant against developers of medical-grade ECG wearables and further push consumer wearables into the remote patient monitoring (https://mhealthintelligence.com/news/cms-ama-look-for-common-ground-on-remote-patient-monitoring) landscape.

While Apple hasn’t said anything about its plans, Bloomberg and other news outlets (http://www.chicagotribune.com/bluesky/technology/ct-apple-watch-ekg-heart-monitor-20171226-story.html) have reported on a project that would equip the Apple Watch with a sensor that tracks electrical signals in the heart. The sensor would be an upgrade to current consumer- facing smartwatches and activity bands that use green LED lights and light0-sensitive photodiodes to measure blood flow through the wrist.

Medical device makers like AliveCor, BioSig, Biotricity and Medtronic currently dominate a market primarily focused on clinicians seeking to monitor patients’ ECGs outside the office or clinic. More recently, companies like Cardea, Motiv and Qardio have come out with ECG monitors fit into stylish wearables and designed for the consumer market.

Most ECG tests are undertaken in a doctor’s office or clinic, and serve to help clinicians identify heart rate irregularities such as atrial fibrillation, which is responsible for some 130,000 deaths and 750,000 hospitalizations per year in the US.

Some 6 million Americans are living with AFib and are five times more susceptible to sustaining a stroke, with one in every three experiencing a stroke in his or her lifetime, according to the Centers for Disease Control and Prevention. More importantly, as many as 30 percent of those living with AFib haven’t been diagnosed.

For many years the standard of care delivery for mobile ECGs has been the Holter monitor, a bulky and expensive device designed to capture ECG rates over a few days. Companies like AliveCor see the mHealth platform as an ideal tool for capturing ECGs on demand and over longer periods of time, giving clinicians a better idea of a patient’s heart health.

Ironically, AliveCor’s KardiaBand – a wristband that tracks ECG – was recently paired with a SmartRhythm app designed for the Apple Watch. The California-based company also announced that the KardiaBand has received U.S. Food and Drug Administration clearance as a medical device accessory, the first such accessory to be approved for the Apple Watch.

“The ECG holds a vast amount of information about a person's overall health, and applying machine learning to millions of ECG recordings is an important enhancement to traditional ECG analysis,” company CEO Vic Gundotra said earlier this year. “We look forward to continuing to apply deep machine learning techniques to uncover hidden physiological signals in ECGs to improve heart and overall human health.”

Apple’s ultimate goal is to combine the two markets, giving clinicians a device that they can trust in tracking a patient’s heart rate, while giving consumers medical-grade health tools in a smartwatch.

The company is currently partnering with Stanford University’s School of Medicine and telehealth vendor American Well on the Apple Heart Study, a clinical research project enabling consumers with cardiac issues to use the Apple Watch and an accompanying app to collect data on irregular heart rhythms who may be experiencing atrial fibrillation (AFib).

If an irregular heart rhythm is identified, study participants will receive a notification on their Apple Watch and iPhone, a free consultation with a study doctor – arranged by American Well - and an electrocardiogram (ECG) patch for additional monitoring. 

Source: Eric Wicklund - mHealth Intelligence