Capsule secures FDA clearance for capnography monitoring solution

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Capsule Technologies has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its capnography monitoring solution Vitals Plus with the Masimo NomoLine ISA CO₂ Module.
Capnography technology is used by clinicians to regularly monitor patient end-tidal carbon dioxide (EtCO₂), respiratory rate (RR) and fractional inspired CO₂ (FiCO₂) for ventilation adequacy and the onset of changes in patients’ cardiovascular and respiratory conditions.
It is also used to evaluate hypoventilation and hyperventilation that indicate respiratory depression or future respiratory failure and arrest.

Vitals Plus with NomoLine capnography identifies the concentration of expired carbon dioxide (CO₂) in an exhaled breath, which indicates ventilation and respiratory adequacy.

It also provides information about the body’s metabolism, perfusion, pulmonary circulation and cardiac function.
The technology can also be used in combination with the company’s Early Warning Scoring System (EWSS) to enable another layer of protection and alerts for caregivers when the deterioration starts.
Masimo’s NomoLine sidestream technology, used with Vitals Plus monitoring, eliminates typical problems related to conventional sidestream gas analysers. These include the need for water traps and issues associated with the handling of the analysers.

In a separate development, medical technology company ControlRad has obtained FDA 510(k) clearance …

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