TOKYO — The Japanese government has approved the Apple Watch installed with its electrocardiogram app as a medical device, heralding an era of advanced wearables that will not just function as fitness trackers but also serve broader medical purposes.
The smartwatch from Apple is Japan’s first EKG device marketed to consumers. Wearing the device allows for round-the-clock monitoring of the heart that could lead to the early detection of coronary diseases.
Previous Apple watches have measured a person’s pulse, or heart rate, but could not measure the heart’s electrical activity. The latest EKG feature is less accurate than conventional machines at a medical office but offers the advantage of detecting arrhythmia at any time.
Doctors in Japan are embracing the new technology. The wrist-worn device will “make testing and diagnosing easier,” said cardiologist Takehiro Kimura at Keio University Hospital in Tokyo.
Kimura, who has used the smartwatch to track exercise levels and weight changes of patients at a clinic in the capital since 2018, showed how he incorporates the device in health care to Tim Cook during the Apple CEO’s 2019 visit to Japan.
“Having records of EKGs in the app will help with diagnosis,” Kimura said. Diagnosing an irregular heartbeat is difficult without an EKG taken at the time the problem occurs, he added.
The app sends alerts in case of irregular readings, which could prompt wearers to see a doctor for early detection and possibly prevent a stroke.
Japan has stated certifying smartphone apps as medical devices since 2014. A smoking-cessation app from Tokyo startup CureApp received approval last month.
The medical wearables industry will grow to $14.4 billion globally in 2022, nearly tripling from $5.3 billion in 2016, U.S. research firm MarketsandMarkets projects. Such expansion is spurring tech giants worldwide to intensify efforts in the field.
Verily Life Sciences, a unit of Google parent Alphabet, obtained approval from the U.S. Food and Drug Administration for the EKG feature of its Verily Study Watch in 2019. Alphabet also announced a $2.1 billion deal last November to acquire wristwatch-style fitness tracker maker Fitbit.
Samsung Electronics has added blood pressure tracking and EKG features to its latest Galaxy smartwatches released in August, with government clearance in South Korea.
Japanese player Omron Healthcare, a unit of Omron, offers the HeartGuide blood pressure monitor watch certified as a medical device. The watch lets users track changes in blood pressure throughout the day with the aim of receiving timely treatment for hypertension and other conditions.
Consumers who do not like to wear a watch likely will have another option soon. Kyoto manufacturer Mitsufuji has developed a shirt with high-accuracy EKG capability in a project to help people with epilepsy. The aim is to issue a warning up to 10 minutes before a seizure based on EKG data. Mitsufuji is collaborating with national institution Tokyo Medical and Dental University.