Blog Tag: AliveCor
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.
The FDA recently cleared the first medical device accessory for the Apple Watch — AliveCor’s KardiaBand. According to AliveCor, the Kardiaband is a mobile, real-time electrocardiogram (EKG) reader that can record an EKG within 30 seconds and display the results on the Apple Watch or iPhone. In conjunction with the KardiaBand, AliveCor is introducing “SmartRhythm, a new feature within the Kardia app for the Apple Watch.”
Portable EKG readers for smart phones are not new; several are on the market already. However, none of them can tell the patient when to take an EKG. The KardiaBand solves that problem. The combination of the KardiaBand and SmartRhythm will use the Apple Watch’s sensors “to continuously evaluate the correlation between heart activity and physical activity,” and alert the user to take an EKG using the KardiaBand when the “heart rate and activity are out of sync.” According to Dr. Eric Topol, director of the Scripps Translational Science Institute,
[The KardiaBand] is continuously monitoring your heart rate to let you know if something is potentially off track. That’s the big difference.
AliveCor eplains that the Kardia app will display the results of the EKG on the Apple Watch and alert the patient if atrial fibrillation (Afib) is detected. If necessary, the results of the EKG can be emailed directly to a physician. Dr. Topol believes that this technology will “markedly increase the number of EKGs taken,” which will potentially save lives, because Afib often goes undetected.
The news of KardiaBand’s approval comes within days of Apple’s announcement of the Apple Heart Study in conjunction with Stanford Medicine, which will investigate the detection of Afib using the sensors already embedded in the Apple Watch. However, in a recent interview, AliveCor’s CEO, Vic Gundotra, distinguished the KardiaBand from the heart rate and activity sensors already found on the Apple Watch:
Apple might be able to say ‘oh your heart rate is high’ …but what does that mean? Does that mean you should go to the hospital? And if you go to the hospital what are they going to do?. Any doctor will say ‘ok come in, let’s get an EKG reading.’ . . . It’s not possible to diagnose atrial fibrillation without FDA clearance. That is a big, big play.
AliveCor touts the FDA’s approval of KardiaBand as a reason patient’s can be confident in the results of AliveCor’s mobile real-time EKG technology. In another interview, Mr. Gundotra stated
The average consumer doesn’t know what a normal sinus rhythm looks like or what atrial fibrillation looks like. Yet the FDA has cleared our individual algorithms. The consumer can have confidence that this is FDA-cleared. And frankly, we have the clinical studies to prove it.
The results of a recent study showed a 4-fold increase in Afib detection when using AliveCor’s mobile 30-second EKG technology. That same study showed that when using mobile EKG technology, such as the KardiaBand or AliveCor’s other device, fewer cases of Afib went undiagnosed.
The KardiaBand is available on AliveCor’s website for $199.
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.