- The U.S. International Trade Commission has opened an investigation into Apple wearable electronic devices in response to a complaint from AliveCor alleging the Apple Watch with ECG functionality violates the Tariff Act.
- The ITC voted to investigate after Mountain View, California-based AliveCor filed a complaint with the agency in April arguing that importing the products for sale in the U.S. infringes three of its patents.
- AliveCor seeks a limited exclusion order that would bar the infringing products from being imported into the U.S. as well as a cease and desist order that would stop Apple from selling the devices already in the U.S.
AliveCor contends Apple illegally incorporated its patented electrocardiogram monitor technology into the Apple Watch.
Apple gained FDA approval in September 2018 for an electrocardiogram monitor to be embedded in its Apple Watch and received a separate De Novo clearance for an application to identify irregular heart rhythms that could suggest AFib. At the time, FDA touted its work with the company as it developed the software, saying the devices could help users seek earlier treatment for health issues.
Before Apple came out with its own ECG app, however, AliveCor launched the first FDA-cleared accessory for the Apple Watch. Called KardiaBand, the application for use with the Apple Watch received FDA clearance in November 2017.
Apple's move ultimately led AliveCor to discontinue sales of the KardiaBand, and in December, AliveCor sued Apple in U.S. District Court in Waco, Texas, for infringement of three patents involving apparatus and methods for diagnosing arrhythmias using specialized sensors in a wearable device.
AliveCor is now focusing on its FDA-cleared KardiaMobile personal ECG device, which is sold directly to consumers and can detect abnormal heart rhythms such as atrial fibrillation. The user places fingers on the sensors of the portable device, and an analysis is sent to a smartphone or tablet in about 30 seconds.
In announcing its investigation into AliveCor's trade complaint, the ITC said the case will be assigned to one of the agency's administrative law judges, who will schedule and hold an evidentiary hearing. The judge will make an initial determination as to whether there is a violation of the Tariff Act, and the commission will review that decision.
The ITC will make a final determination in the investigation and pledged within 45 days to set a target date for completing the probe.