AliveCor seeks to ban Apple Watch from being sold in the United States, accusing its ECG patent infringement | Fierce Healthcare

2021-12-15 01:02:26 By : Ms. Mandy Yang

Health technology company AliveCor, a manufacturer of connected ECG devices, is trying to ban Apple Watch sales in the United States, claiming that the technology giant has infringed on three of its patents.

AliveCor filed a lawsuit with the U.S. International Trade Commission (ITC) on Tuesday, accusing Apple of infringing on AliveCor's three ECG technology patents.

The company also accused Apple of trying to eliminate the company's competitors.

Apple did not respond to a request for comment.

AliveCor's ITC complaint was filed four months after it filed a lawsuit against Apple, alleging that Apple Watch Series 4, 5 and 6 infringe the same three patents, which all involve the ability to monitor and track arrhythmias.

Related: AliveCor receives FDA approval for Apple Watch accessories for the first time

In a lawsuit filed in the U.S. District Court for the Western District of Texas, AliveCor claimed that its patents were “novel, unconventional, and focused on the use of dedicated sensors in wearable devices to improve specific methods and methods of existing heart monitoring technology. " 

According to the lawsuit, AliveCor also argued that Apple was aware of these patents when it created the Series 4, 5 and 6 Apple Watch.

The complaint to ITC "is a step AliveCor is taking to obtain relief against Apple’s deliberate copying of AliveCor’s patented technology (including the ability to read electrocardiograms and heart rate analysis on Apple Watch)-as well as Apple’s heart rate on Apple Watch Analyze the market’s efforts to eliminate competition from AliveCor,” the company said in a press release announcing ITC’s complaint.

In 2017, AliveCor was approved by the U.S. Food and Drug Administration (FDA) to sell medical device accessories for Apple Watch. The regulatory nod covers AliveCor's KardiaBand, a device that clips to an Apple smartwatch and performs ECG readings. This is the first Apple Watch accessory approved by the FDA.

A year later, Apple launched the Series 4 smartwatch with ECG approved by the FDA and officially classified it as a medical device that can alert users to abnormal heart rhythms.

Related: AliveCor nets $65 million, FDA approves future telemedicine plan

In 2019, AliveCor's mobile 6-lead ECG device was approved by the FDA, and its two-electrode device was also approved by the FDA for the detection of bradycardia and tachycardia, which are the two most common irregular heartbeats.

In November, AliveCor received US$65 million in Series E financing to develop its remote monitoring platform and announced that its new generation ECG reading algorithm has been approved by the FDA, which can detect a wider range of arrhythmias and potential heart diseases . According to Crunchbase, the company has raised $154 million so far.

The company stated in a press release that, starting in 2011, AliveCor has "invested heavily in providing consumer users with advanced, artificial intelligence-driven heart detection technology."

These investments resulted in the KardiaMobile product, a personal electrocardiogram device; KardiaMobile 6L, a six-lead personal electrocardiogram; KardiaBand, the first FDA-approved Apple Watch medical device accessory; and SmartRhythm, which uses artificial intelligence to continuously evaluate heart activity Whether there are signs of arrhythmia.

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