Capsule Technologies has received FDA 510(k) clearance for its Vitals Plus monitoring solution with the Masimo NomoLine ISA CO2 module, according to the company.
Vitals Plus with NomoLine capnography measures the concentration of expired carbon dioxide in expired or exhaled air – an immediate indicator of ventilation and respiratory adequacy. Capnography is the monitoring of the concentration or partial pressure of exhaled CO2, which provides information about the body’s metabolism, perfusion, pulmonary circulation and cardiac function. The technology can also be used in conjunction with Capsule’s Early Warning Scoring System (EWSS) to enable another layer of protection and alerts for caregivers when deterioration is beginning to happen.
“The ability to continuously monitor CO2 levels keeps patients safer by identifying deterioration faster than other methods,” said Hemant Goel, CEO of Capsule. “Our partnership with Masimo gives clinicians a convenient way to add this important measurement for immediate use and automatically add the measurement data to the patient record with other patient vital signs. This FDA 510(k) clearance also helps expand Vitals Plus into more low- and mid-acuity care settings, including more opportunities to help hospitals monitor patients receiving opioids, which is an increasingly important application for capnography.”
Masimo is a leading global medical technology company that develops and manufactures innovative noninvasive patient monitoring technologies. Its NomoLine sidestream technology, used with Vitals Plus monitoring, eliminates common problems associated with conventional side stream gas analyzers, including the need for water traps and issues related to their handling.
Capsule’s Vitals Plus monitors a patient and sends validated or unvalidated vital signs data to the electronic health record (EHR) right from the bedside, enabling clinicians to focus on direct caregiving. When linked with Capsule Surveillance, Vitals Plus and other medical devices can feed critical patient information to surveillance algorithms that intelligently alert caregivers to important changes in patient status. The capnography module can be shared between multiple monitors to provide flexibility based on patient needs. The capnography module also will be available as an accessory that can be added to specific Vitals Plus monitors already in hospitals.
