CASMED's Fore-Sight cleared to monitor skeletal muscle
This article was originally published in Clinica
Executive Summary
The US FDA has expanded the 510(k) clearance Fore-Sight Absolute Tissue Oximeter, manufactured by CAS Medical Systems (CASMED), to include skeletal muscle monitoring. Specifically, it is now cleared for this use in infants, children and adolescents weighing 5-50kg. The device was previously cleared to continuously and noninvasively measure oxygen saturation of blood in the brains of critically-ill patients. The expansion will improve monitoring for these patients, Branford, Connecticut-based CASMED believes. Low oxygen saturation levels can indicate anaemia, low cardiac output and shock; monitoring allows clinicians to intervene before the situation becomes life-threatening.
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