However, now only the Medtronic Revo system has obtained FDA approval, while the other products have Conformité Européenne (CE) marks and currently Advisa MRI, Accent MRI, and Evia Pro MRI are ...
“For over 20 years, Medtronic took advantage of its monopoly position in this category and chose not to innovate, develop full-body MRI compatible sacral neuromodulation devices, or invest in ...
Imricor’s work over past 18 years developing the world’s only MRI-compatible devices for cardiac ablation procedures is ...
The feasible combination of leads and devices from different manufacturers leads to a loss of MRI-compatibility in every case. Thus far, only specially designated pacemaker systems from Medtronic ...
The Revo MRIâ„¢ Pacing System with SureScan® technology has met the rigors of clinical evaluation, regulatory review, and FDA approval. Specifically Engineered for the MRI Environment ...
The U.S. FDA urged doctors and patients to use CT imaging if possible, when the MRI compatibility of any electronic implanted devices is unknown because problems with CT imaging are "extremely low" in ...
The Centers for Medicare & Medicaid Services granted transitional pass-through (TPT) payment status to Medtronic and Recor Medical for renal denervation devices to treat high blood pressure.
The FDA recently announced critical recalls on several widely used medical devices, including Life2000 ventilators, Medtronic's MiniMed insulin pumps and Boston Scientific's Obsidio conformable ...
Gimbel has shown how device patients may undergo carefully ... Another aspect of concern is that the first generations of Medtronic MRI-compatible PPMs (EnRhythm Sure scan) and the Biotronik ...