FDA Cleared MedTech Patient Monitoring

FDA clears Capsule Technologies’ addition of Masimo tech to patient monitor


Capsule Technologies has received FDA 510(k) clearance for its Vitals Plus patient monitor with the Masimo NomoLine ISA CO2 module, Capsule announced today.

Capnography technology enables clinicians to continuously monitor patient end-tidal carbon dioxide (EtCO2), respiratory rate (RR) and fractional inspired CO2 (FiCO2) for ventilation adequacy and the onset of changes in patient cardiovascular and respiratory conditions. Capnography is used to assess hypoventilation and hyperventilation, which can indicate respiratory depression or impending respiratory failure and arrest.

The addition of NomoLine capnography now allows Vitals Plus to measure the concentration of expired carbon dioxide in expired or exhaled air — an immediate indicator of ventilation and respiratory adequacy. The technology can also be used in conjunction with Capsule’s Early Warning scoring system 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 Capsule CEO Hemant Goel in a news release. “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.”

When linked with Capsule Surveillance, Vitals Plus and other medical devices can feed critical patient information to surveillance algorithms that  alert caregivers to important changes in patient status. The capnography module can be shared among 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.


Original Article: (http://feedproxy.google.com/~r/MedicalDesignAndOutsourcing/~3/rK9P5RDqIVE/)