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FDA clears surface ECG, intracardiac multichannel recording system
BioSig Technologies announced that the company received 510(k) clearance from the FDA for its surface ECG and intracardiac multichannel device to detect the cause of arrythmias in patients with atrial fibrillation.
The PURE EP System is a surface ECG and intracardiac multichannel recording system that acquires and interprets high-fidelity cardiac recordings during ECG studies and catheter ablation procedures, according to a press release from the company. More accurate targeting could result in reduced repeat catheter ablation procedures. The system aims to minimize noise and artifacts and acquire high-fidelity cardiac signals, to potentially increase the diagnostic value of the signals and yield improved accuracy and efficiency, according to the release.
“The PURE EP System is designed to cut through the background noise of the lab and its equipment during cardiac recordings, enabling physicians to target and neutralize the areas of the heart that are causing atrial fibrillation and ventricular tachycardia,” Kenneth L. Londoner, chairman and CEO of BioSig Technologies, said in the press release.
This clearance allows for first-in-man studies using this device, according to the press release. Preclinical studies have been performed between 2015 and 2018 at Mayo Clinic, UCLA Medical Center and Mount Sinai Hospital.
Disclosure: Londoner is an employee of BioSig Technologies.