Will Apple Shake up the Medical Device Industry After FDA’s Recent Decision?

The Apple Watch’s atrial fibrillation tracking features have been given the green light to be used in clinical studies. What does this mean for other companies in the ECG space?

May 6, 2024

2 Min Read
Image Credit: Smith Collection/Gado/Getty Images

At a Glance

  • Apple's foray into medtech has been met with controversy, with debates over the transformative impact of its offerings.
  • The new feature could potentially act as a catalyst by driving interest in pre- and post-therapeutic monitoring.

Apple is shaking up medtech headlines again, but this time it doesn’t involve a high-profile patent lawsuit with AliveCor or Masimo.

The consumer giant is garnering attention after FDA certified the Apple Watch’s atrial fibrillation tracking features to be used in clinical studies.

FDA said the Apple Atrial Fibrillation History Feature is the first digital health technology qualified under the MDDT program.

The device is designed to be used as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices. It is also designed to be used throughout the clinical study, both before and after cardiac ablation treatment, to monitor a study participant’s weekly estimate of AFib burden.   

Apple is no stranger to the medical device industry and in many instances has been a source of controversy for some in medtech. 


In 2018, the company won a nod from FDA for its ECG app and another for its software-only mobile medical app analyzing pulse rates for irregular rhythms. The controversy came from Apple claiming the app and clearance were transformative for the industry – but others pointed to more robust offerings from AliveCor and iRhythm Technologies.

Related:7 Key Moves That Helped Apple Take a Bite Out of Healthcare

Margaret Andrew, an analyst with William Blair, said the Apple Watch update probably wouldn’t impact established technologies like iRhythm’s patch.

“While we are not ignoring the trend of multifunction tools like the Apple Watch expanding their use-case over time, several points in the approval and article suggest to us that this update is not a meaningful risk to iRhythm’s opportunity and may even prove to be a tailwind as it has in recent years with its ECG application by driving interest in pre- and post-therapeutic monitoring,” Andrew wrote.

She added, “Even with the update, Apple Watch does not allow cardiologists or physicians to use the watch for medical diagnosis nor is the watch itself 510(k) [cleared] for medical use. Finally, we note that it is intended for individuals already diagnosed with atrial fibrillation, not the vast majority of iRhythm’s market opportunity, and cannot be used in conjunction with Apple Watch’s irregular heart rhythm notifications.

Andrew noted that the company's sensor technology also limits it from being a major competitive threat to iRhythm.

"While it remains to be seen how this tool evolves over time, inherently the data generation from Apple Watch today remains limited due to the type of sensor technology it uses," she wrote. "This may certainly evolve over time but would likely require a new device, a second complementary data source, or partnership with a third-party technology, which we have not seen to date.”

Related:Apple Asks Appeals Court to Reverse Smartwatch Import Ban as Masimo Patent Battle Continues

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