The Food and Drug Administration (FDA) has granted 510(k) clearance of Linshom’s first product – a non-invasive respiratory monitor.

The Linshom Respiratory Monitoring Device (LRMD) is used to monitor patients who are susceptible to respiratory depression and compromise.

Ashish K. Khanna, professor of anesthesiology and section head for research at Wake Forest Baptist Health, said: “Lack of continuous respiratory monitoring (CRM) 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 4-8 hours, leaving patients unmonitored for most of their hospital stay. Clinical deterioration is often missed or belatedly recognised when the patient is in crisis.”

The LRMD provides clinical staff an accurate measure of respiratory rate, seconds since last breath and relative tidal volume (RTV). RTV is a critical parameter previously unavailable outside of the operating room, intensive care unit or post anesthesia care unit.

Richard Hughe, Linshom CEO, said: “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 that we hit our milestones and advance the value of the company with their investment.”