Tag: Simpson Interventions

Simpson Interventions Announces both IDE approval from FDA for Acolyte™ Catheter System and 510(k) clearance for its Shadow Catheter™, adds Board Member

CAMPBELL, Calif.–(BUSINESS WIRE)–Simpson Interventions, Inc., a pioneering medical technology company, specializing in cardiovascular interventional devices, today announced achievement of major development milestones. Its truly unique Acolyte™ Image-Guided Crossing and Re-Entry Catheter System has been granted an Investigational Device Exemption by the U.S. Food and Drug Administration (FDA), after having been […]

Simpson Interventions Announces Appointment of Dr. Joseph Knight as CEO

June 12, 2024 10:00 AM Eastern Daylight Time CAMPBELL, Calif.–(BUSINESS WIRE)–Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced the appointment of Dr. Joseph Knight to the role of Chief Executive Officer, effective May 1st, 2024. He replaces Simpson Interventions’ Founder and previous CEO, […]

Simpson Interventions Accepted into FDA’s TAP Pilot Program for Breakthrough Device, Acolyte™ Catheter System

CAMPBELL, Calif.–(BUSINESS WIRE)–Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced its acceptance into the Total Product Life Cycle Advisory Program Pilot (TAP Pilot) by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). “This acknowledgment underscores […]

Simpson Interventions Receives FDA Breakthrough Device Designation for Acolyte™ Image Guided Crossing and Re-Entry Catheter System

CAMPBELL, Calif.–(BUSINESS WIRE)–Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced that its groundbreaking Acolyte Image Guided Crossing and Re-Entry Catheter System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). “We are thrilled to receive FDA’s Breakthrough Device […]