One of the splashier medtech moments of 2018—when it comes to an FDA 510(k) decision, that is—was the agency’s de novo clearance of the latest Apple Watch and its software allowing on-demand electrocardiograms for the mass-market consumer.
While the FDA classifying Apple’s new Series 4 smartwatch as a medical device was news enough, one of the more interesting facets of its launch last September—and the Cupertino giant’s cannonball leap into healthcare—was the company’s choice to pitch the watch as indispensable to the elderly and not just toward the tech-focused early adopter set.
With new gyroscope hardware, the watch can detect hard falls and call for help automatically if needed, which could be a boon for seniors, particularly those who live alone. Apple is in discussions with private Medicare plans and insurance companies about subsidizing the cost of the device for those over age 65.
Meanwhile, its single-lead ECG takes only 30 seconds to classify sinus rhythms as normal, inconclusive or atrial fibrillation, a common arrythmia. Each recording is saved to the user’s iPhone and can be shared with physicians in PDF format. The smartwatch can also monitor pulse rates in the background for additional warning signs of afib.
That background monitoring works with the heartbeat sensors found in earlier versions of the Apple Watch, which enabled a massive clinical study with Stanford University. The devices polled 400,000 U.S. users over eight months to investigate the smartwatch’s ability to correctly detect the irregular heart rhythm.
Though only 0.5% of the Apple Heart Study’s participants received an alert of potentially abnormal activity, that still amounted to more than 2,000 people, who were then connected with a doctor for a telehealth consultation and given an ECG chest patch for further monitoring.
Only 34% of those 2,000 people were actually diagnosed with atrial fibrillation, though 57% had sought medical attention, highlighting the potential for false alarms. The stats also served as a caution against relying on the Apple Watch as a hard diagnostic. Positive readings did coincide 84% of the time, however, among those wearing both the watch and the patch.
Going forward, Apple plans to enlist Johnson & Johnson to help put its smartwatch through the clinical wringer: A multiyear study will test whether the latest smartwatch can diagnose elderly users with afib faster than more traditional means. The smartwatch will also be paired with a J&J-designed patient engagement and drug adherence app to gauge the potential for improving cardiovascular outcomes and preventing strokes.