FDA Revises Impulse Dynamics Optimizer Smart Device Labeling Opening it to More Patients
Change removes requirement for normal sinus rhythm
Stay updated with breaking news from Optimizer Smart. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
Change removes requirement for normal sinus rhythm
Change removes requirement for normal sinus rhythm
European Union Allows MRI Scans of Heart Failure Patients With Impulse Dynamics Implanted Optimizer Smart Devices Impulse Dynamics Optimizer Smart device is an implantable device that helps optimize cardiac pumping action in heart failure patients. March 3, 2021 — Impulse Dynamics recently announced that DEKRA Certification B.V., a global regulatory organization, approved labeling for the Optimizer Smart device for conditional full-body magnetic resonance imaging (MRI) scans utilizing 1.5 Tesla scanners in the European Union (EU). DEKRA, known for ensuring the safe use of medical devices in...
(2) Impulse Dynamics Receives Medical Device Approval for European Union to Safely Administer MRI Scans for Heart Failure Patients with Implanted Optimizer Smart Devices MARLTON, N.J., Feb. 16, 2021 (GLOBE NEWSWIRE) -- 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 us...
Posted on 189 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 by Dr. Edvaldo Xavier, cardiologist at Santa Casa de Maceió in Maceió, Alagoas. “It was with enormous satisfaction that we were able to perform the first Optimizer Smart CCM implant in Brazil, a new therapy for eligible patients with heart failure...