ReddyPort has received 510(k) premarket clearance from the US Food and Drug Administration (FDA) for its elbow device intended for non-invasive ventilation (NIV).
The elbow device has a self-sealing valve, which offers seamless oral access to the patient’s mouth without the requirement for mask removal.
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It helps reduce the risk of therapeutic pressure loss besides maintaining lung compliance.
ReddyPort’s elbow empowers bedside clinicians by providing them with access to a range of oral care appliances, including suction swabs, applicator swabs, Yankauers and toothbrushes, for routine Q2/Q4 oral care and dry mouth relief.
The device also minimises the risk of unplanned mask removal, which is expected to result in pressure injuries, re-fitting processes and improperly fitted masks.
Furthermore, it allows patients and clinicians to utilise the ReddyPort microphone.
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By GlobalDataThe microphone amplifies audible speech tones and reduces background noise, enabling patients to better communicate with caregivers and family members.
Under the FDA emergency use authorisation, the ReddyPort elbow provided 45,000 compliant oral care sessions to patients.
ReddyPort CEO Tony Lair said: “ReddyPort’s patented elbow is central to the eco-system we are building to help mitigate clinical obstacles tied to NIV therapy from dry-mouth, oral biofilm accumulation to speech recognition.”
NIV is the first line of therapy for patients with respiratory insufficiency or failure commonly associated with conditions such as acute respiratory distress syndrome, chronic obstructive pulmonary disease, congestive heart failure, pneumonia and asthma.
