AliveCor has secured two additional FDA clearances for its personal electrocardiogram, allowing it to detect bradycardia and tachycardia arrhythmias.
Along with its previous 510(k) clearance for atrial fibrillation, the company’s KardiaMobile device is now the only consumer-focused product that can spot the three most common irregular heartbeats, according to the former Fierce 15 winner.
In addition, the device can detect atrial fibrillation at a pulse above 120 beats per minute, as well as heart rates below 40.
"Until today, patients have been frustrated when devices label their ECG reading as 'unclassified' or 'inconclusive,'” CEO Ira Bahr said in a statement. “Starting today, KardiaMobile is the first personal ECG device that can begin to materially reduce the number of those determinations.”
It’s a shot at the latest version of the Apple Watch, equipped with its own, built-in ECG, which has only been cleared for atrial fibrillation. To put it through the clinical wringer, Apple is teaming up with Johnson & Johnson on a multi-year research study to see if the smartwatch can diagnose elderly patients earlier. A separate study of 400,000 participants tested previous versions of the Apple Watch that detected potential AFib rhythms using its simple pulse rate sensor, and not an ECG.
But periods of fast and slow heart rates—either above 100 or below 50 beats per minute—are often benign and occur in nearly all adults, although they can indicate heart disease or conditions such as thyroid disease, or cause symptoms like dizziness or shortness of breath. AliveCor hopes the greater range of its product will provide more peace of mind than returning an “unclassified” reading.
"Tachycardia and bradycardia are common because they are often the body's natural response to everyday life, from physical activity and sleep to emotions and overall health," said Jacqueline Shreibati, AliveCor’s chief medical officer. "While we have traditionally focused on the patient empowerment that comes from increased awareness of atrial fibrillation, we are excited to give all of our users more actionable insights into their heart health."
AliveCor has also recently signed onto a partnership to expand its reach into the Chinese market, where 300 million people suffer from heart disease, including about 10 million living with atrial fibrillation. The deal with healthcare service provider Beijing Dream Tree Medical Technology will help supply its pocket-sized device to the country.