CardioMEMS ran into a regulatory roadblock last week, when an FDA advisory panel recommended that the agency not approve the company's Champion HF Monitoring System. The device is said to be the first ...
December 8, 2011 (Gaithersburg, Maryland) — An FDA advisory panel collectively decided a tiny pulmonary-artery (PA) pressure monitor for patients with heart failure (HF) isn't ready for prime time.
Nearly 6.7 million adults in the U.S. have heart failure, with prevalence expected to rise to 8.5 million by 20301,2. While heart failure is a chronic, progressive disease, advances in technology are ...
Oak Ridge, TN, March 23, 2023 (GLOBE NEWSWIRE) -- Daxor Corporation (DXR) (NYSE: DXR), the global leader in blood volume measurement technology, today announces new data validating the benefits of the ...
Atlanta, Georgia-based health device maker CardioMEMS received FDA clearance for its CardioMEMS HF System, which monitors pulmonary artery pressure, but for patients who have experienced New York ...
Oak Ridge, TN, July 12, 2023 (GLOBE NEWSWIRE) -- Daxor Corporation (NASDAQ: DXR), the global leader in blood volume measurement technology, today announces a new research letter in the Journal of the ...
WASHINGTON (Reuters) - A Food and Drug Administration review of CardioMEMS' device for treating heart failure found it has met its main safety and effectiveness goals, based on trial results. But the ...
Columbus, OH - Heart-failure patients managed with a wireless implantable hemodynamic monitoring system had a significant and large reduction in hospitalizations compared with standard management, ...
WASHINGTON, Dec 5 (Reuters) - U.S. health regulators on Monday said a CardioMEMs implant for treating heart failure met its main safety and effectiveness targets but warned of potential bias in the ...
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