LifeShirt.com software indications expanded by FDA:
This article was originally published in Clinica
LifeShirt.com's R&D partner Non-Invasive Monitoring Systems has received US FDA 510(k) clearance for an expanded indication for its RespiEvents software package, which is used with LifeShirt.com's ambulatory patient monitor. The monitor, which is not yet approved in the US, resembles a shirt with embedded sensors to monitor continuously a patient's vital signs during daily activities. The new indication allows for the analysis of breathing patterns as an aid to diagnosing apnoea and hypopnoea, said LifeShirt.com of Ojai, California.