Seattle-based Mirador Biomedical has won FDA clearance to market its medical device for a new set of uses, which doctors have been asking about for months.
Mirador said today that its digital pressure sensor technology, which it calls its Compass platform, is now cleared by the FDA for a half dozen different medical uses. The Mirador device was first approved in October 2010 for a couple of specific uses—helping medical staff determine when they are about to make a dangerous mistake by inserting a catheter into the wrong type of blood vessel, or the wrong part of the spinal column. The new FDA approvals mean that Mirador can now pitch its product to doctors for its ability to measure additional things like “compartment pressure” which is sometimes helpful in battlefield injury settings, or elevated intra-abdominal pressure, which can make people sick.
The private company doesn’t disclose its revenues, but co-founder and CEO Karl Schmidt says that “hundreds” of hospitals have used the Mirador digital sensor in the past year, and revenues have been increasing each month. The new uses should double the potential market for its products, Schmidt says, and will free the company up to start actively marketing the technology for uses that its customers have been suggesting it pursue for months. While Mirador is legally able to sell its products for uses other than those approved by the FDA, and physicians are able to prescribe products for unapproved uses, companies can’t legally promote new drugs or devices in the U.S. for specific uses unless they are cleared by the FDA.
“This is important because it allows us to push other uses physicians have found for the device,” says Justin Hulvershorn, Mirador’s co-founder and chief science officer.
The company is betting that hospitals will pay for its technology to help prevent costly medical errors, and because it provides greater convenience in everyday workflow than existing methods that rely on somewhat clumsy cables and equipment.
Mirador got its first FDA approval after less than two years of work, and little more than $1 million of investment. Last April, Mirador pulled in another $1.5 million in financing for its commercial plans. WRF Capital, Summit Capital, and various local angel investors have backed the company so far.