A judge at the U.S. International Trade Commission (ITC) ruled that Apple Watch ECG technology infringed the AliveCore ECG patent.
AliveCor is an American company co-founded by David Albert who began developing ECGs for handheld computers in 1990 and patent the wireless transmission of ECGs in handheld devices in 1998. The company received FDA approval for its first medical accessory for Apple Watch “EKG Kardia band” in 2017.
Found guilty of patent infringement, Apple Watch could be barred from import into the U.S.
In 2018, Apple introduced the ECG app in Apple Watch Series 4 for users to take an electrocardiogram (ECG or EKG) anywhere and at any time to monitor the timing and strength of the electrical signals of their heartbeat and to detect undiagnosed atrial fibrillation (AFib), a form of irregular rhythm.
In March 2021, AliveCor filed a lawsuit against the tech giant accusing it of “illegally” monopolizing the market for heart rate apps for Apple Watch. The filing detailed that the tech company intentionally changed the heart rate algorithm which made it impossible for the users of AliveCor’s SmarthRhtym app to receive notifications to take an ECG on their Apple Watch and rendered its ‘EKG-Kardia’ band usefulness.
In April last year, AliveCor also filed a complaint at ITC seeking to bar U.S. importation of Apple’s smartwatches over infringement of three AliveCor patents.
On June 27, 2022, an Administrative Law Judge (ALJ), Cameron Elliot of ITC found Apple infringed AliveCor’s patented technology which was affirmed by full ITC. The court could issue an order to halt the import of Apple Watches into the United States.
In a press release, the CEO of AliveCor, Priya Abani said:
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. Since the start, our focus has been on our customers and providing them with strong choices to help monitor their cardiac health, including KardiaBand, the first-ever FDA-cleared ECG device accessory for Apple Watch.