FDA approves Linshom’s Respiratory Monitoring Device

The Food and Drug Administration (FDA) has approved Linshom’s Respiratory Monitoring Device (LRMD), designed to provide clinical staff with precise breathing rate estimations, relative tidal volume and the amount of time since last breath. Furthermore, the system monitors patients who are vulnerable to breathing difficulties and depression.

Wake Forest Baptist Health’s Section Head for research and Professor of Anesthesiology, Ashish K. Khanna, stated: “Lack of continuous respiratory monitoring is a major clinical problem as nearly half of all adverse events in hospitalised patients occur on the general care floor. Current general care floor monitoring consists of intermittent nursing checks every four-eight hours, leaving patients unmonitored for most of their hospital stay. Clinical deterioration is often missed or belatedly recognised when the patient is in crisis.”
Linshom CEO, Richard Hughe stated: “This is our first FDA clearance for the company so it is a major milestone. Clinically, this clearance brings us closer to commercial launch of a product that may reduce morbidity and mortality by monitoring respiratory rate, and tidal volume continuously, thus allowing for prediction of impending respiratory failure and prompt intervention. Financially, this clearance provides current and future investors’ confidence