FDA News

FDA expands arrhythmia indications for ECG smartphone app

Jacqueline Shreibati
Jacqueline Shreibati

AliveCor announced that its consumer ECG device received two 510(k) clearances by the FDA for its ability to detect bradycardia and tachycardia.

This ECG technology (KardiaMobile) has previously been cleared by the FDA to detect atrial fibrillation and normal sinus rhythm, according to a press release from the company. This device is paired with the Apple Watch and can instantly analyze ECGs and detect any arrhythmias.

“These FDA clearances improve all of our users' experience with Kardia by reducing the number of unclassified results they receive when recording ECGs, Jacqueline Shreibati, MD, chief medical officer for AliveCor, told Cardiology Today. “The additional indications are for arrhythmias which are generally low risk and common in day-to-day life, and therefore provide necessary insights to patients and their doctors and will create a more informed dialogue between them.”

The device can also detect heart rates above and below other available technologies.

“Critically, KardiaMobile is … the only personal ECG that can detect atrial fibrillation at heart rates above 120 (beats per minute) and heart rates below 40 (beats per minute),” Ira Bahr, CEO of AliveCor, said in the release.

The device’s ability to detect arrhythmias may help patients talk with their doctors about their condition, according to the release.

“While often benign, these arrhythmias may be suggestive of heart disease or other health conditions, such as thyroid disease,” Shreibati said in an interview. “These updates essentially provide peace of mind to our users who may have otherwise received an unclassified reading. Now, with bradycardia or tachycardia, users can ease their concerns and also provide their doctors with insights needed to detect potential heart concerns early on.” – by Darlene Dobkowski

Disclosures: Bahr and Shreibati are employees of AliveCor.

Jacqueline Shreibati
Jacqueline Shreibati

AliveCor announced that its consumer ECG device received two 510(k) clearances by the FDA for its ability to detect bradycardia and tachycardia.

This ECG technology (KardiaMobile) has previously been cleared by the FDA to detect atrial fibrillation and normal sinus rhythm, according to a press release from the company. This device is paired with the Apple Watch and can instantly analyze ECGs and detect any arrhythmias.

“These FDA clearances improve all of our users' experience with Kardia by reducing the number of unclassified results they receive when recording ECGs, Jacqueline Shreibati, MD, chief medical officer for AliveCor, told Cardiology Today. “The additional indications are for arrhythmias which are generally low risk and common in day-to-day life, and therefore provide necessary insights to patients and their doctors and will create a more informed dialogue between them.”

The device can also detect heart rates above and below other available technologies.

“Critically, KardiaMobile is … the only personal ECG that can detect atrial fibrillation at heart rates above 120 (beats per minute) and heart rates below 40 (beats per minute),” Ira Bahr, CEO of AliveCor, said in the release.

The device’s ability to detect arrhythmias may help patients talk with their doctors about their condition, according to the release.

“While often benign, these arrhythmias may be suggestive of heart disease or other health conditions, such as thyroid disease,” Shreibati said in an interview. “These updates essentially provide peace of mind to our users who may have otherwise received an unclassified reading. Now, with bradycardia or tachycardia, users can ease their concerns and also provide their doctors with insights needed to detect potential heart concerns early on.” – by Darlene Dobkowski

Disclosures: Bahr and Shreibati are employees of AliveCor.