Tag: Impulse Dynamics

Impulse Dynamics’ Quality Management System Receives Certification Under European Union Medical Device Regulation

Impulse Dynamics Is Now Among the First US-based Manufacturers of Active Implantable Devices To Receive Certification MARLTON, N.J., March 22, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a company dedicated to innovative treatments for chronic heart failure, is pleased to announce that it has successfully completed the requirements for certification of […]

Impulse Dynamics Announces First Patient Enrolled in AIM HIGHer — Implantable Device Trial to Treat Heart Failure in Higher EF Population

Trial Evaluates FDA-Designated Breakthrough Therapy for Patients Who Lack Treatment Options MARLTON, N.J., March 14, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), today announced that the first patient has been enrolled in the quadruple-blinded sham-controlled […]

IMPULSE DYNAMICS RECEIVES FDA APPROVAL TO MODIFY LABELING FOR OPTIMIZER SMART MEDICAL DEVICES

FDA Authorizes Removal of “NSR” From Indications for Use MARLTON, N.J., Oct. 26, 2021 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), today announced that the U.S. Food and Drug Administration approved a modification of labeling for […]

IMPULSE DYNAMICS RECEIVES APPROVAL TO SELL OPTIMIZER CCM DEVICES IN CHINA

NMPA Clears the Way for Impulse Dynamics to Deliver Hope for Heart Failure Population MARLTON, N.J., Feb. 22, 2021 (GLOBE NEWSWIRE) — Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced that the National Medical Products Administration (NMPA) approved the application for […]

Impulse Dynamics Announces FDA Approval for Magnetic Resonance Imaging

FDA Clears Potential Hurdle for Many Heart Failure Patients MARLTON, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has approved the conditional use of Magnetic Resonance Imaging (MRI) for Optimizer® CCM® delivery systems. This approval […]

Impulse Dynamics Announces First Heart Failure Patient Treated With CCM Therapy in Brazil

Breakthrough Therapy Now Commercially Available in South America’s Most Populous Country MARLTON, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a company dedicated to helping healthcare providers improve the lives of people with heart failure, today announced the first patient in Brazil was treated with its innovative CCM® therapy delivered by the Optimizer® system. The patient was treated […]

Impulse Dynamics Announces CCM Therapy Delivered by the Optimizer System Wins R&D 100 Award

Breakthrough heart failure therapy recognized as a revolutionary innovation MARLTON, N.J.–(BUSINESS WIRE)–Impulse Dynamics, Inc., a company dedicated to improving the lives of people with heart failure, today announced its innovative CCM® therapy delivered by the Optimizer® system received an award from the R&D 100 Awards, a prestigious program honoring research and development pioneers […]