Simpson Interventions Receives the US FDA’s 510(k) Clearance for its Shadow Catheter and IDE Approval for its Acolyte Catheter System

Shots: Simpson Interventions reported the grant of IDE by the US FDA to Acolyte Image-Guided Crossing & Re-Entry Catheter System plus 510(k) clearance for its Shadow Catheter Acolyte System intends to enables cardiologists with revascularization of coronary chronic total occlusion (CTO). In Mar 2024, it was designated with the US FDA’s BDD and included…