Blog Tag: Heart Monitor

Apple Watch Found to Infringe AliveCor ECG Patents

Apple Watch Found to Infringe AliveCor ECG Patents

AliveCor, Inc., a company focused on cardiac data and remote medicine, successfully convinced an International Trade Commission (ITC) judge that Apple, Inc. infringed multiple AliveCor patents related to electrocardiogram (ECG) technology.  AliveCor asserted that the Apple Watch (Series 6 and 7) infringes multiple AliveCor ECG patents and seeks to ban the watches from importation into the U.S.

In a June 27, 2022 Notice of Initial Determination, an ITC Administrative Law Judge (“ALJ”) agreed with AliveCor, determining Apple had violated Section 337 of the Tariff Act of 1930 (19 U.S.C. § 1337), related to “Unfair practices in import trade.”  The ALJ found the ECG functionality of the Apple Watch Series 6 and Series 7 (pictured below) infringed multiple, valid claims of two AliveCor patents: U.S. Patent Nos. 10,638,941 (titled “Discordance Monitoring”) and 10,595,731 (titled “Methods and Systems for Arrhythmia Tracking and Scoring”).

AliveCor is the complainant in ITC Investigation No. 337-TA-1266 (the “1266 Investigation”), captioned Certain Wearable Electronic Devices with ECG Functionality and Components Thereof.  A public version of the ALJ’s complete Initial Determination should be released soon.  By October 26, 2022, the full ITC is expected to issue a final decision in the 1266 Investigation.  If the Commission affirms the ALJ’s findings, the Apple Watch Series 6 and Series 7 could be banned from importation into the United States.

AliveCor, Inc., Maker of Smart Phone-Based ECG Device, Receives FDA Clearance for Two New Algorithms that Provide Users Immediate Feedback

AliveCor, Inc., Maker of Smart Phone-Based ECG Device, Receives FDA Clearance for Two New Algorithms that Provide Users Immediate Feedback

San Francisco-based AliveCor,Inc. recently announced that the U.S. Food and Drug Administration (FDA) granted the company clearance for two new algorithms for its Smart Phone-based ECG device, the AliveCor Heart Monitor and its accompanying AliveECG app.

The press release states that:

AliveCor’s new analysis processes (algorithms) include a Normal Detector that identifies when no abnormalities are detected in an ECG recording and an Interference Detector that identifies if factors have affected the recording making the ECG unreadable. Together with the previously cleared atrial fibrillation (AF) detection algorithm (AF Detector), these two new detectors will continue to ensure patients and their healthcare providers receive accurate and relevant real-time interpretations of mobile ECG recordings.

According to the press release, these algorithms are designed to provide immediate notification to patients, which allows them to alleviate anxiety over arrhythmias when they are reassured that their ECG is normal, and allows for the delivery of more efficient care and follow-up by allowing healthcare providers to focus on reviewing ECGs that are the most concerning.

The press release further states that the AliveCor Heat Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health conscious individuals in order to record, store and transfer single-channel ECG rhythms. AliveCor’s website notes that the AliveCor Heart Monitor and its accompanying AliveECG app are compatible with all iOS and most Android OS mobile devices.