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FDA clears credit card-sized personal ECG machine

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For just $149, consumers can now carry a personal ECG (electrocardiogram) device in their wallet.

The FDA has cleared AliveCor’s KardiaMobile card, which the Mountain View, Calif.-based company describes as “the thinnest, most convenient personal ECG device ever.”

The size of a standard credit card, the KardiaMobile card is designed to fit in any wallet and deliver a medical-grade single-lead ECG in 30 seconds.

“After disrupting traditional ECG monitoring with our revolutionary Kardia platform, we have taken an unprecedented step by creating the first-ever credit card-sized personal ECG,” said Priya Abani, CEO of AliveCor. “KardiaMobile Card delivers the most sophisticated AI in the most convenient form factor ever, putting the power of real-time ECG analysis directly into patient wallets and furthering our vision of becoming the 24/7 virtual cardiologist. /7 for patients when they are not in front of their doctor.”

KardiaMobile Card pairs with a smartphone using Bluetooth technology to detect six of the most common arrhythmias, more than any other personal ECG on the market, according to AliveCor. KardiaMobile Card users also have access to cardiac ECG analysis, monthly heart health reports, and automatic sharing of ECG recordings. The device’s algorithm is based on AliveCor’s AI-enabled Kardia technology, which has been evaluated by over 170 peer-reviewed studies. Designed to withstand weather, water, and wear, the KardiaMobile Board is AliveCor’s most portable and durable ECG available, allowing users to take an ECG recording anytime, anywhere. or.

“The availability of a personal ECG that fits in a wallet will change the face of remote cardiac monitoring for patients and healthcare professionals,” said Darria Long Gillespie, MD, emergency physician and clinical assistant professor of medicine. Emergency, AliveCor Ambassador, and Founder of TrueveLab. “As someone living with ventricular tachycardia and having treated patients with arrhythmia, I know how critical it is to access accurate, real-time ECG recordings. KardiaMobile Card has made this technology even easier to access, and it quickly became the most valuable card in my wallet.”

The KardiaMobile card comes with one-year access to KardiaCare, the heart health service that offers more than 130,000 members a suite of advanced features to help them better manage and understand their heart health. KardiaCare includes ECG evaluations by board-certified cardiologists, monthly reports that summarize ECG and blood pressure data, automatic sharing of ECG recordings with caregivers, and the ability to detect a wider range of heart conditions.

Evolution of the personal ECG market

About a year ago, MD+DI editor Omar Ford hosted Dave Albert, MD, co-founder and chief medical officer of AliveCor, on an episode of the Let’s Talk Medtech podcast to discuss the evolution of the personal ECG market and significant successes of the company.

“Today, the idea that someone can record their own ECG using a device they have purchased over the counter, and if they wish, send that data to their doctor for review and to help take care of them, I think that’s an accepted notion today, just as it’s accepted that you can prick your finger and test your blood sugar,” Albert said. “When I was a student in medicine in the late 1970s, you had to go to a doctor to have your blood sugar tested. Imagine the millions of diabetics they can’t even think that’s how it should be managed because blood sugar goes up and down with exercise and food… so now we know we can measure our blood sugar, we can take our blood pressure we can record our ECG, we can do a lot of things that were previously only done in a doctor’s office or a hospital.

So while the evolution of the personal ECG market has exceeded his expectations, Albert said he has also gone “down the path of this thing we call digital health.”

Use the player below to listen to the full conversation between Ford and Omar.