- Acutus Medical ( NASDAQ: AFIB ) filed an application to the U.S. Food & Drug Administration (FDA) seeking approval of its AcQBlate Force Sensing Ablation Catheter and System.
- The premarket approval application (PMA) was backed by data from a study called AcQForce Flutter which evaluated the system for treating right atrial typical flutter, the company said in a statement on Tuesday.
- Atrial flutter is a form of abnormal heart rhythm.
- The company intends to present full data from the trial at the AF Symposium in February 2023.
For further details see:
Acutus files for FDA approval of catheter ablation system AcQBlate