cardiac contractility modulation therapy News
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Global Regulatory Organization Certifies Optimizer Smart Device as Compliant for Whole-Body MRI Scans in the EU
Impulse Dynamics, an international medical device company dedicated to improving the lives of people with heart failure (HF), today announced that DEKRA Certification B.V. (DEKRA), a global regulatory organization, approved labeling for the Optimizer® Smart device for conditional full-body MRI scans utilizing 1.5 Tesla scanners in the EU. DEKRA, known for ensuring the safe use of ...
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Impulse Dynamics Announces First Optimizer Implant in China
Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure, today announced the first implantation of a patient in China with its innovative Optimizer system delivering CCM therapy. Cardiologist Dr. Hua Wei from the renowned Fuwai Hospital of the Chinese Academy of Medical Sciences performed the successful implant procedure. Dr. Wei shared, ...
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Impulse Dynamics Receives Approval to Sell Optimizer CCM Devices in China
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 market authorization of the Optimizer® CCM® device for patients with heart failure in the People’s Republic of China. HF impacts several million citizens in China, and ...
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Impulse Dynamics Receives FDA Approval to Modify Labeling for Optimizer Smart Medical Devices
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 the Optimizer Smart medical device, allowing the removal of “normal sinus rhythm” (NSR) from the indications for use statement. Since patients are no longer ...
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