HeartBeam's Groundbreaking ECG Technology: Commercialization and FDA Submission FAQ
TL;DR
HeartBeam's FDA-submitted 12-lead ECG software offers a competitive edge in cardiac care with its cable-free technology for faster arrhythmia detection.
HeartBeam's software synthesizes 12-lead ECG data from cable-free recordings to assess arrhythmia severity and guide treatment through FDA clearance.
HeartBeam's technology improves global heart health by enabling earlier detection of atrial fibrillation to reduce stroke risk and save lives.
HeartBeam is revolutionizing ECG monitoring with cable-free technology that detects hidden arrhythmias like atrial fibrillation during everyday activities.
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HeartBeam is developing a breakthrough, cable-free ECG technology designed to transform how atrial fibrillation is detected and managed.
HeartBeam has submitted its 12-lead ECG synthesis software for arrhythmia assessment to the U.S. Food and Drug Administration for 510(k) clearance.
ECG data is necessary for the diagnosis of all cardiac arrhythmias in order to assess severity, implications and treatment options.
Atrial fibrillation is one of the most typical sustained arrhythmias in adults that can cause palpitations and is associated with increased health risks, though it is often asymptomatic.
The company is building the infrastructure needed to support widespread adoption of its ECG technology to enable smooth commercialization.
The latest news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT.
FDA 510(k) clearance is a regulatory pathway that would allow HeartBeam to market its 12-lead ECG synthesis software for medical use in the United States.
Palpitations are common in heart health, with most occurring during normal sinus rhythm, and atrial fibrillation can be one cause of palpitations.
Curated from InvestorBrandNetwork (IBN)
