Volta Medical announced that it received FDA clearance for its VX1 artificial intelligence software for interventional cardiac electrophysiology.
Marseille, France-based Volta’s AI-based tool is a machine- and deep-learning algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria during Afib or atrial tachycardia, according to a news release.
The company said the detection and patient-specific localization of abnormal regions may eventually help physicians better decide where they need to intervene to burn (radiofrequency) or freeze (cryotherapy) faulty electrical pathways.
Volat believes the VX1 system offers an easier, faster and more accurate way to identify zones of interest in patients suffering from chaotic heart muscle contractions.
“Our ultimate goal is to offer an alternative to a lifetime of medication that can have problematic side effects in some patients, while bringing a better quality of life to those who suffer from bothersome daily disease symptoms,” Volta co-founder Dr. Jérôme Kalifa said in the release. “This is what is generating increasing enthusiasm around the potential of our solution. The recently obtained FDA clearance is an important milestone for our company and ultimately for patients who suffer from difficult to treat forms of AFib.”