The FDA also accepted the technology into its Total Product Lifecycle Advisory Program (TAP). TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices.

Field Medical was founded by Dr. Steven Mickelsen, the founder of Farapulse. Mickelsen also serves as CEO. He led his previous PFA technology developer to an acquisition by Boston Scientific in 2021. Boston Scientific, Medtronic and Johnson & Johnson MedTech now have their PFA technology FDA-cleared.

The FDA breakthrough nod and TAP acceptance cover the FieldForce system for sustained monomorphic scar-related ventricular tachycardia (VT). Field Medical says its system represents the first and only PFA system designed specifically for ventricular arrhythmia ablation.