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

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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 […]

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

Coronary/Structural Heart by 0 comments

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 […]

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

Coronary/Structural Heart by 0 comments

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 […]

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