Mirador Biomedical Wins FDA Approval for Tool to Prevent Dangerous Hospital Errors

Xconomy Seattle — 

Seattle’s medical device community has another member of the commercial club—a company that found a way to reach the marketplace after less than two years of work and with only a little more than $1 million of investment.

Mirador Biomedical, the startup with a digital sensor that can tell the difference when a syringe pokes into a vein or an artery, has won FDA clearance to start selling the product in the U.S. The company also received FDA approval to market a similar device to accurately measure pressure when a medical pro makes a lower back (lumbar) puncture, like the ones done for spinal tap procedures.

The original product for distinguishing between veins and arteries is designed to make sure doctors and nurses don’t inadvertently insert a catheter into a high-pressure artery, when they think it’s a vein. A puncture wound like that can create a life-threatening emergency, as one of Mirador’s founders explained back in this feature story from July. The Mirador tool could be incorporated into central venous procedures that are performed 6 million times a year in the U.S., and may have potential to prevent thousands of mistakes that can cause severe complications, or even death.

“This device has the potential to dramatically reduce the risk” of hitting an artery, which can help patients avoid needless complications, said Andrew Bowdle, the chief of the division of cardiothoracic anesthesiology at University of Washington and lead investigator of a clinical trial Mirador is planning to test its device.

Mirador is one of those companies that was born in a downturn and found a way to get to the market on a relative pittance: a $1.1 million investment made last March. The company, founded in the spring of 2009 by Karl Schmidt, Justin Hulvershorn, and Doug Swartz, pulled together the idea, the basic technology, and the business plan after talking to doctors about simple product ideas that could make a real difference in treating patients. You can read more about the story of the company’s founding in this feature from July.