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.