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Capsule Receives FDA 510(k) Clearance for Vitals Plus Monitor - Margaret Kelly - 09-16-2020

Capsule Receives FDA 510(k) Clearance for Vitals Plus Monitor with Masimo NomoLine[sup]®[/sup] ISA™ CO2 Module
Addition of capnography monitoring can help healthcare providers recognize deteriorating patient conditions, including respiratory depression
ANDOVER, MA — September 15, 2020 — Capsule Technologies has received FDA 510(k) clearance for its Vitals Plus monitoring solution with the Masimo NomoLine ISA CO2 module, the company 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 is particularly important as an indicator of respiratory depression or impending respiratory failure and arrest. Capnography is commonly used to assess the return of spontaneous circulation after cardiac arrest and has applications across the care spectrum, in both high and low acuity settings, from surgery and intensive care to the general care unit and emergency departments.
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.
About Capsule Technologies
Capsule Technologies is a leading global provider of medical data technologies for hospitals and healthcare organizations. Our Medical Device Information Platform — comprised of device integration, vital signs monitoring, and clinical surveillance solutions — captures streaming clinical data from connected systems and transforms it into context-rich information for clinical documentation, alarm management, patient surveillance, decision support, predictive analytics, clinical research and more. End-to-end data management and connectivity supports better collaboration and communication between clinicians and departments. More than 2,900 global clients leverage our platform to improve patient safety, simplify workflows and raise overall satisfaction throughout the hospital and across care settings. Learn more at www.capsuletech.com.