AW promotion. the latest news about the market leader when it comes to monitoring your heart
Fourth borderThe New York and Bangalore-based medical technology company has announced 510(k) clearance for Frontier X Plus from the US FDA.
The Frontier X Plus is an innovative single-link, continuous ECG monitor that is worn around the chest and wirelessly transmits the user’s ECG instantly to remote panels. A number of advanced algorithms identify and classify the heart rhythm as bradycardia, tachycardia, normal sinus rhythm or atrial fibrillation.
The device demonstrated best-in-class signal quality during a range of motions, including intense exercise. The wearable ECG monitor further demonstrated equivalence in the classification of cardiac arrhythmias when compared to a conventional 12-lead ECG through clinical trials in India and the US.
Paula Radcliffe (The Fourth Frontier)
According to the Centers for Disease Control, one person dies from cardiovascular disease (CVD) every 33 seconds, and CVDs are responsible for one in five deaths in the United States. The American Heart Association reports that between three and six million Americans have reported cases of atrial fibrillation. This number is expected to increase to 16 million by 2050.
Atrial fibrillation has been described as a global epidemic and is a major indicator of reduced morbidity and mortality in individuals of all age groups. Globally, the incidence and prevalence of cardiovascular disease (CVD) is increasing in young people and is one of the leading causes of premature death.
“We’ve seen cardiac arrhythmias develop in people of all ages, and the incidence is significantly higher in individuals who are both active and have heart health risk factors,” said Manav Bhushan, Fourth Frontier’s co-founder and CEO. “The percentage of the population that falls into the amalgamation of these categories is constantly increasing. Because FX+ is able to capture ECGs during all types of movement and activity, we believe this will be a game-changer and significantly improve the early detection of cardiovascular disease.”
With this approval, the company plans to enter the US market as a prescription-only Class II medical device. The Fourth Frontier will partner with Independent Diagnostic Testing Facilities (IDTFs) and cardiac rehabilitation centers to offer remote home monitoring services.
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