Capsule secures FDA clearance for capnography monitoring solution

16 September 2020 (Last Updated September 16th, 2020 15:01)

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.

Capsule secures FDA clearance for capnography monitoring solution
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. Credit: Rcp basheer.

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 for ControlRad Trace use on OEC 9900 Mobile C-arms.

The device is designed to reduce unwanted radiation during fluoroscopically guided procedures while ensuring image quality in the region of interest or overall workflow.

ControlRad president and executive vice-president Chris Fair said: “This additional FDA clearance allows us to offer the critically important protection of our radiation reduction technology to even more patients and staff in need of mobile C-arm related procedures.”

The company also closed a Series C financing round led by current investor Questa Capital.