FDA clears Mirador’s pressure sensing products
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for Mirador Biomedical’s Compass Vascular Access and Compass Lumbar Puncture, its two lead products. The former is a pressure sensor for use during the insertion of central venous catheters, while the latter is used to measure pressure during lumbar puncture. The Compass Vascular Access device can help physicians distinguish between arteries and veins by measuring blood pressure, which is shown on a digital display. This reduces the risk of puncturing an artery, which can lead to death from stroke, airway compression or haemorrhage. Seattle, Washington-based Mirador claims that its Compass Lumbar Puncture product is more accurate than manometry, the standard method of measuring pressure during the procedure, which quantifies muscle pressure.