NEW YORK , Nov. 13, 2024 /PRNewswire/ -- Fourth Frontier , 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 an innovative single-lead, continuous ECG monitor that is worn around the chest and wirelessly relays the user's ECG instantly to remote dashboards. A range of advanced algorithms identify and classify cardiac rhythm as Bradycardia, Tachycardia, Normal Sinus Rhythm, or Atrial Fibrillation.
The device demonstrated best-in-class signal quality during a range of motions including during intense exercise. The wearable ECG monitor further demonstrated equivalence in the classification of cardiac arrhythmias when compared with the conventional 12-lead ECG, through 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 expected to rise to 16 million by 2050. Atrial Fibrillation has been described as a global epidemic and is a key indicator of reduced morbidity and mortality in individuals of all age groups.
Globally, the incidence and prevalence of Cardiovascular Disease (CVD) has been increasingly observed in younger individuals and is one of the leading reason.