FDA clears new device for assisting in non-invasive ventilation

Patient using breathing device with ReddyPort elbow.

The U.S. Food and Drug Administration has granted 510(k) premarket clearance for a new elbow device used in non-invasive ventilation (NIV) for patients with COPD, asthma, pneumonia and other breathing-related conditions.

The ReddyPort elbow device features a self-sealing valve that provides seamless oral access to the patient’s mouth without the need for mask removal. This, in turn, alleviates the risk of therapeutic pressure loss and maintains lung compliance during treatment.

NIV failure can happen because the mask used can lead to persistent dry-mouth, biofilm formation, skin breakdown and difficulty communicating. This failure can in turn lead to invasive ventilation, higher costs, longer hospital stays and diminished patient outcomes.

“ReddyPort’s patented elbow is central to the ecosystem we are building to help mitigate clinical obstacles tied to NIV therapy from dry mouth and oral biofilm accumulation to speech recognition,” said ReddyPort CEO Tony Lair.

The elbow works with ReddyPort’s oral care appliances including toothbrushes, suction swabs and applicator swabs to allow for routine oral care and dry-mouth relief while minimizing unplanned mask removal.

In addition, the elbow also enables patients and clinicians to use the ReddyPort microphone, which amplifies audible speech tones and minimizes background noise, allowing patients to communicate with their caregivers and family members.

Non-invasive ventilation is the first line of therapy in respiratory insufficiency or failure as seen with COPD, asthma and other conditions. It is also used to help wean patients off mechanical ventilation.

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