AliveCor, the leader in AI-based personal ECG technology and provider of enterprise cardiology solutions, announced that the US FDA had given clearance to the company's next generation of interpretive ECG algorithms.“Kardia AI V2 is the most sophisticated AI ever brought to personal ECG. This suite of algorithms and visualizations will provide the platform for delivery of new consumer and professional service offerings beyond AFib, by allowing a much wider range of cardiac conditions to be determined on a personal ECG device,” said Priya Abani, CEO, AliveCor.“The Kardia Mobile and Kardia Mobile 6L devices, along with the Kardia app, allow users to take a 30-second ECG and receive instant determinations of multiple cardiac conditions, she added.The FDA 510(K) clearance provides detail and fidelity unlike any previously seen in personal ECG devices including a sinus rhythm with premature ventricular contractions (PVCs) determination if two or more ventricular ectopic beats are detected. PVCs are a common occurrence where extra heartbeats originate in the bottom chamber of the heart and occur sooner than the next expected regular heartbeat. After the PVC beat, a pause usually occurs, which causes the next normal heartbeat to be more forceful. When one feels the heart “skip a beat,” it is this more forceful beat that is felt.The company expects the new suite of advanced determinations will augment telehealth services and provide the technology foundation for a new range of professional and consumer services including the launch of advanced ECG determination services within KardiaCare, the company's remote heart care service for consumers. It also covers Kardia Heart Health Report (HHR), a cardiologist-backed patient heart risk assessment report. There is also a professional ambulatory monitoring service, using the AliveCor six-lead ECG device at home, bringing greater comfort and convenience over legacy technologies. There is chronic heart disease management, which combines human-backed and digital care plans to manage the heart health of high-risk employee populations.This new FDA clearance positions us to deliver AI-based remote cardiological services for the vast majority of cases when cardiac patients are not in front of their doctor. AliveCor's goal is to help cardiologists efficiently provide the best possible 24/7 service to their patients, she said.As the most clinically validated personal ECGs globally, KardiaMobile and KardiaMobile 6L provide instant detection of normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia. The new determinations and services will be available in 2021
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