AliveCor seeks to bar U.S. sales of Apple Watch alleging ECG patent infringement

AliveCor KardiaMobile
AliveCor has secured FDA clearances for its personal electrocardiogram device, KardiaMobile. The company has filed a complaint with the U.S. International Trade Commission, alleging Apple’s infringement of three AliveCor ECG technology patents. (AliveCor)

Health technology company AliveCor, maker of connected electrocardiogram devices, is trying to ban U.S. sales of the Apple Watch, claiming the tech giant allegedly infringed on three of its patents.

AliveCor filed a complaint Tuesday with the U.S. International Trade Commission (ITC) alleging Apple’s infringement of three AliveCor ECG technology patents.

The company also has accused Apple of trying to eliminate the company as a competitor.

Apple did not respond to a request for comment.

AliveCor's ITC complaint comes four months after it filed a lawsuit against Apple alleging that the Apple Watch Series 4, 5, and 6 infringed the same three patents, which all deal with the ability to monitor and track arrhythmia.

RELATED: AliveCor gets first FDA nod for an Apple Watch accessory

In the lawsuit, filed in the U.S. District Court for the Western District of Texas, AliveCor claimed its patents are “novel, unconventional and focus on specific means and methods of using specialized sensors in a wearable device to improve upon existing cardiac monitoring technology.” 

AliveCor also contends that Apple was aware of these patents when it created the Series 4, 5, and 6 Apple Watches, according to the lawsuit.

Filing the complaint with the ITC “is one step, among others, AliveCor is taking to obtain relief for Apple’s intentional copying of AliveCor’s patented technology—including the ability to take an ECG reading on the Apple Watch, and to perform heart rate analysis—as well as Apple’s efforts to eliminate AliveCor as competition in the heartrate analysis market for the Apple Watch," the company said in a press release announcing the ITC complaint.

In 2017, AliveCor gained clearance from the Food and Drug Administration (FDA) to sell a medical device accessory for Apple Watch. The regulatory nod covered AliveCor’s KardiaBand, a device that clips onto Apple’s smartwatch and performs ECG readings. It was the first FDA-cleared Apple Watch accessory.

A year later, Apple unveiled its Series 4 smartwatch that included an FDA-cleared ECG, officially classifying it as a medical device capable of alerting its user to abnormal heart rhythms.

RELATED: AliveCor nets $65M, new FDA clearances for future telehealth plans

In 2019, AliveCor secured FDA clearance for its mobile 6-lead ECG device and also gained the agency's green light for its two-electrode device to spot bradycardia and tachycardia, two of the most common irregular heartbeats.

In November, AliveCor scored a $65 million series E funding round to grow its remote monitoring platforms and also announced it had secured FDA clearance for its new generation of ECG-reading algorithms that spot a wider range of arrhythmias and potential heart conditions. The company has raised $154 million to date, according to Crunchbase.

Starting in 2011, AliveCor has "invested heavily in bringing advanced, AI-powered cardiological detection technology to consumer users," the company said in the press release.

These investments have produced the KardiaMobile product, a personal ECG  device; the KardiaMobile 6L, a six-lead personal ECG; the KardiaBand, the first FDA-cleared medical device accessory for Apple Watch; and SmartRhythm, which uses artificial intelligence to continuously evaluates heart activity for signs of arrhythmias.