Pulse Abandons 510(k) Submission for PFA Device Following FDA’s Request for Clinical Data
Pulse Biosciences has announced a significant shift in its regulatory strategy for the Cellfx cardiac clamp, a pulsed field ablation (PFA) device initially being guided through the 510(k) pathway for clearance. The company initially filed for 510(k) clearance in January, but after the Food and Drug Administration (FDA) requested human data, Pulse has now decided […]