NEW YORK, Nov. 13, 2024 — , a medical technology company based out of New York and Bangalore, announced the 510(k) clearance of the Frontier X Plus from the U.S. FDA. The Frontier X Plus is a cutting-edge, single-lead, continuous ECG monitor that is worn on the chest and transmits the user’s ECG data wirelessly to remote dashboards in real-time. Its advanced algorithms can identify and categorize heart rhythm as Bradycardia, Tachycardia, Normal Sinus Rhythm, or Atrial Fibrillation. The device demonstrated exceptional signal quality during various movements, including vigorous exercise. The wearable ECG monitor further demonstrated its ability to classify cardiac arrhythmias with accuracy comparable to conventional 12-lead ECG, as confirmed by clinical trials in India and the US.
According to the Center for Disease Control, one person dies every 33 seconds from Cardiovascular Disease (CVD), and CVDs are responsible for one in every five deaths in the US. The American Heart Association reports that between three to six million Americans have reported an incidence of Atrial Fibrillation. This number is projected to increase to 16 million by 2050. Atrial Fibrillation has been characterized as a global epidemic and is a significant indicator of reduced morbidity and mortality for individuals of all ages. Worldwide, the occurrence and prevalence of Cardiovascular Disease (CVD) have been increasingly observed in younger individuals and is one of the leading causes of premature death.
“We have observed cardiac arrhythmias developing in individuals of all ages, and the incidence is significantly higher for individuals who are both active and have cardiac health risk factors. The portion of the population that falls within these categories is continuously growing. As the FX+ is capable of capturing ECGs during all types of motion and activity, we believe this will be a game changer and significantly enhance the early detection of cardiovascular disease,” stated Manav Bhushan, co-founder and CEO of Fourth Frontier.
With this clearance, the company plans to enter the US market as a prescription-based, Class II medical device. Fourth Frontier will collaborate with Independent Diagnostic Testing Facilities (IDTFs) and cardiac rehabilitation centers to provide at-home remote monitoring services. In the near future, the company intends to introduce AI algorithms that analyze ECG data for early diagnosis of various heart conditions, a potential breakthrough for individuals using the device in their daily lives.
About Fourth Frontier:
Fourth Frontier is a pioneering health tech company that develops and offers products and services for monitoring and improving heart health for people globally.
Cardiovascular disease is the leading cause of mortality worldwide. Despite its significance, affordable products and services to monitor and improve heart health from the comfort of the home have not been readily available to consumers. Fourth Frontier is committed to addressing this crucial problem.
With over 150 million minutes of data, 120,000+ users, and a presence in 4,000+ cities across 50+ countries, the device is trusted by individuals who want to enhance their heart health and fitness.
To learn more about Fourth Frontier, please visit , or follow us on or .
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