AliveCor ECG patent ruling sets stage for block on Apple Watch imports – MedTech Dive

This audio is auto-generated. Please let us know if you have feedback.

Dive Brief:

  • An administrative law judge with the International Trade Commission (ITC) found Apple infringed AliveCor’s patents in a case that could bar the import of its smartwatch device into the U.S. 
  • AliveCor sold an ECG wristband accessory for Apple Watch until the incorporation of arrhythmia detection capabilities into the device itself led AliveCor to pull its product from the market in 2019. Two years later, AliveCor filed a complaint with the ITC.
  • In an initial determination, the ITC judge found AliveCor has proven infringement of multiple claims for two patents. If affirmed by the full commission, the ruling could lead to an order barring U.S. imports of infringing Apple Watches.

Dive Insight:

AliveCor became the first company to introduce an FDA-cleared accessory for the Apple Watch in 2017. The KardiaBand and associated software assessed whether the wearer’s heart rate and physical activity were out of sync and asked them to use the device to take an ECG to check for evidence of atrial fibrillation. 

Apple ended the need for an ECG accessory late in 2018 when it incorporated an ECG app and irregular heart rhythm notifications into the Apple Watch Series 4. After initially seeking to differentiate KardiaBand, AliveCor stopped selling the product within months of the introduction of a native ECG app for the wearable. 

AliveCor hit back through the legal system last year, filing a complaint with the ITC in April and following up with an anticompetition complaint against Apple in May. The ITC has now shared its initial ruling ahead of the release of its final determination in October. While Apple beat AliveCor on some counts, the ITC found violations of the Tariff Act of 1930 in relation to two patents. 

“Today’s ruling is a strong validation of our IP and underscores that patents matter and even an influential company like Apple cannot simply violate them to stifle innovation,” AliveCor CEO Priya Abani said in a statement.

Apple did not return requests for comment at the time of publication. 

The ITC found AliveCor has proven the infringement of multiple claims against two patents, while failing to prove infringement of a third patent. Apple proved some of the infringed claims invalid. If upheld in the final ruling, the violations could lead to an exclusion order barring the importation of infringing Apple Watches into the U.S.

According to Apple’s consumer-facing website, the Series 7 Apple Watch, which retails for $399 and up, is the only watch now on sale that has an ECG function, which the company likens to a single-lead echocardiogram. While Apple would not release details on the number of smart watches that could be affected by an ITC decision, the company shipped more than 32 million wearables in the first quarter of 2022, and Apple holds about 30% of the global wearable market, according to the International Data Corporation.


This website uses cookies. By continuing to use this site, you accept our use of cookies.