Puget Sound Business Journal (Seattle) - by Clay Holtzman
This week, Seattle medical device company Mirador Biomedical is expected to learn whether the Food & Drug Administration has approved its new pressure sensor device for catheter injections.
Company CEO Karl Schmidt says he expects to hear back from the FDA soon. On Wednesday, it will be 90 days since Mirador filed its 510(k) application with the FDA, which states that it aims to get back to applicants within 90 days of filing. Schmidt said he doesn’t expect there to be any major problems with the device.
“We don’t anticipate us having to make any serious design changes,” Schmidt said. Mirador submitted its application in March of this year; the review process takes about 90 days.
The Compass Vascular Access device attaches to a needle and measures pressure of blood flow at the point of insertion, which is displayed in a digital gauge. The device can identify whether the needle used to insert a catheter is puncturing a vein or an artery. If approved, the sensors will cost between $20 and $50 apiece.
Mirador is preparing 1,500 units ahead of the FDA decision, but it is capable of producing between 50,000 and 100,000 units a year, Schmidt said.Schmidt says Mirador has been talking with 10 hospitals that are interested in using the device, while a dozen of them want to test it.
The co-director of emergency medicine research at Seattle Children’s Research Institute, Julie Brown, plans to test the Compass device for its secondary application: lumbar (back) injections in children. That research is funded by a $150,000 grant from the Washington State Life Sciences Discovery Fund.Schmidt said that on the high end, his company’s device could sell into a market worth about $200 million a year.
If the Compass device is approved, Mirador could get an early jump on putting the device in front of potential clients. The company will be attending the annual meeting of the American Society of Anesthesiologists from Oct. 16-20 in San Diego.
