Mirador Biomedical, a medical device developer in Seattle, Washington, says that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for two of its products. A 510(k) clearance is required from FDA to market medical devices, where the manufacturers need to demonstrate the safety and effectiveness of the devices.
The Compass Vascular Access, made by Mirador Biomedical, provides pressure measurements during the insertion of central venous catheters. An integrated guidewire port allows for guidewire insertion with pressure guidance. The company says the device can reduce potential serious injury from missing the target vein and puncturing an artery.
The company’s Compass Lumbar Puncture, receiving FDA clearance as well, is a similar device to measure pressure during lumbar puncture, also known as a spinal tap. Mirador Biomedical says clinical trials are planned for both products.
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