Revolutionizing Heart Health: Frontier X Plus Gains FDA Clearance
Nov 13, 2024
New York [US], November 13: 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.
