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Home » CardioStory’s Cardiac Monitor Designated an FDA Breakthrough Device
CardioStory’s Cardiac Monitor Designated an FDA Breakthrough Device
The FDA has designated CardioStory’s noninvasive filling-pressure heart monitor as a Breakthrough Device.
The proprietary sensor technology, which delivers results in two minutes, may have favorable accuracy compared with ultrasound and physical examination by an experienced physician, the company said.
In a trial, the device demonstrated 89 percent accuracy compared with the standard of care, an invasive heart catheter to measure pulmonary capillary wedge pressure, CardioStory said.
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