New Apple Watch receives FDA clearance for built-in ECG

An app unlocking the wrist-based ECG functionality will be available to U.S. consumers later this year, following its FDA classification as a Class II device. (Apple)

The latest iteration of Apple’s smartwatch includes an FDA-cleared electrocardiogram, officially classifying it as a medical device capable of alerting its user to abnormal heart rhythms.

Much speculation has surrounded when and how the tech giant would jump into the healthcare waters—and it did so with a large splash, unveiling the new Series 4 model and its federal de novo clearance at Apple’s iPhone launch event in Cupertino, California.

Additionally, through new accelerometer and gyroscope hardware, the Apple Watch can detect hard falls by analyzing wrist trajectory and impact.

Your Daily Newsletter — Free

Enjoying this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. To read on the go, sign up today to get biotech news and updates delivered right to your inbox!

The watch then sends the user an alert that can be used to call for help. If the watch senses no motion for 60 seconds after the fall, it will automatically call emergency services and notify emergency contacts with its location.

In a statement, FDA Commissioner Scott Gottlieb, M.D., and CDRH Director Jeffrey Shuren, M.D., J.D., described Apple’s new clearances as part of a “reimagination” of healthcare delivery.

“The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly,” they said. “Healthcare products on ubiquitous devices, like smartwatches, may help users seek treatment earlier and will truly empower them with more information about their health.”

In addition, the agency leaders described how a broad swath of new companies have begun investing in digital healthcare opportunities, including through ride-sharing apps and virtual home assistants—and may not be fully versed in navigating the regulatory landscape.

Gottlieb and Shuren pointed to the FDA’s digital health action plan unveiled last year, aimed at streamlining approvals for software posing a lower risk than traditional medical devices.

As it first wades into the market, Apple’s inclusion of both fall detection and ECG support appear to be targeting an older generation of potential users—portraying the device as a must-have for more than just tech-focused millennials.

In fact, the FDA’s letters to Apple classifying the watch’s software as a Class II device—dated Sept. 11 (PDF), the day before the launch event—state that the ECG app is not intended for use by people under age 22.

“The completely redesigned Apple Watch Series 4 continues to be an indispensable communication and fitness companion, and now with the addition of groundbreaking features, like fall detection and the first-ever ECG app offered directly to consumers, it also becomes an intelligent guardian for your health,” said Jeff Williams, Apple’s chief operating officer.

RELATED: Apple launches Health Records with 39 health systems. How soon will it reach clinical studies?

An app unlocking the wrist-based ECG functionality will be available to U.S. consumers later this year. Using electrodes built into the watch’s crown and a new heart rate sensor, users touch and hold the side of the watch while it sends an electric current through the chest to the opposite hand. 

After about 30 seconds, the device measures heart rhythms, classifies them, and alerts the user if there are signs of atrial fibrillation. The Apple Watch also intermittently analyzes heartbeats in the background for irregularities, or if it exceeds or falls below a specified threshold.

All its data recordings and any noted symptoms are stored in the watch’s Health app in a PDF that can be shared with physicians.

Previously, ECG-capable Apple Watch attachments have been available, such as the FDA-cleared AliveCor KardiaBand. Earlier this year, AliveCor and the Mayo Clinic showed that a trained AI network could help identify patients at risk for arrhythmias and sudden cardiac death using data from simple, portable ECG devices.

Correction: This post has been updated to reflect that the Apple Watch offers an electrocardiogram, not an echocardiogram.