FDA clears Aspect's Bispectral Index products:
This article was originally published in Clinica
Executive Summary
Aspect Medical Systems has received US FDA 510(k) clearance for three new products which the company claims will enhance the versatility and functionality of its Bispectral Index (BIS) devices for monitoring the effects of anaesthetics on the brain. The three products are the BIS Pediatric Sensor, BIS Sensor XP and BIS Module Kit, said the Newton, Massachusetts company.