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June 28, 2016

MGC Diagnostics gets FDA 510(k) clearance for Resmon PRO FULL FOT device

Medical technology company MGC Diagnostics has secured the US Food and Drug Administration (FDA) 510(k) clearance for its Resmon PRO FULL, Forced Oscillation Technique (FOT) device.

Medical technology company MGC Diagnostics has secured the US Food and Drug Administration (FDA) 510(k) clearance for its Resmon PRO FULL, Forced Oscillation Technique (FOT) device.

The device enables US healthcare professionals to non-invasively monitor a patient’s lung mechanics and normal breathing pattern, eliminating the need of forced efforts with traditional measurements.

The Resmon PRO FULL is suited for use for elderly patients as well as children aged four and above.

"The device is suitable for critically ill patients as it requires less patient movement during the process."

MGC Diagnostics CEO Todd Austin said: "The Resmon PRO FULL is designed to provide medical professionals the ability to measure mechanical properties of the respiratory system during normal tidal breathing, providing a simple, effort-independent assessment for both clinicians and patients."

Developed by Restech Respiratory Technology, the FOT features low dead space circuit which is aligned to anxiety tension state (ATS) and erythrocyte sedimentation rate (ERS) standards.

It supplements spirometry with information on mechanical properties of the respiratory system that otherwise may not be accessible via the conventional pulmonary function tests.

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The device is suitable for critically ill patients as it requires less patient movement during the process.

The existing spirometry maneuver can hinder the effectiveness of a bronchodilator while the tidal breathing manuever of FOT has the ability to pronounce the effectiveness of a bronchodilator.

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