pNeuton Mini Infant Critical Care Transport Ventilator with nCPAP Receives FDA Approval

pNeuton Mini Infant Critical Care Transport Ventilator with nCPAP Receives FDA Approval

Press Release Dec 04, 2012

MELBOURNE, FL (Dec 3, 2012) - Airon Corporation is proud to announce that their new pNeuton mini—an innovative ventilator designed specifically for neonatal/infant/pediatric life support in hospitals, MRI and transport—has been approved by the FDA for sale in the USA.

With the increasing use of non-invasive ventilation in neonates, this new ventilator opens the door to providing nasal CPAP (nCPAP) or ventilation during transport and, most importantly, in the MRI.The pNeuton mini is the world’s first infant ventilator that gives healthcare professionals the potential to support the smallest of patients, 400 grams to 25 kg, throughout the care continuum.

“Receiving FDA approval along with acquiring CE mark approval earlier this year provides the pNeuton mini with global authorization for clinical use,” said Eric Gjerde, President and CEO, Airon Corporation.

The pNeuton mini is ideal for areas such as labor & delivery, remote hospital locations, surgical procedure support, or the MRI—areas in the hospital where healthcare professionals need a variety of ventilation support levels with patient alarms. This ventilator is more versatile than other infant ventilators, providing full ventilatory support with variable flow rate control, 6–20 L/min or nasal CPAP for spontaneous breathing. It has a full range of oxygen delivery from 21% to 100% and pure pneumatic technology which eliminates the need for any batteries. The pNeuton mini meets airworthiness criteria and is rugged enough for all transport conditions. 

EMS World selected the pNeuton mini as one of the top products of 2012; the pNetuon mini was awarded a 2012 EMS World Innovation Award.

Airon has released the pNeuton mini for global shipments with the first deliveries scheduled for Airon’s distributors in South Africa, Malaysia, Saudi Arabia, and the USA. Discover the versatility that makes the pNeuton mini a smart choice in infant transport ventilation. Visit www.AironUSA.com

ABOUT AIRON

Airon Corporation is dedicated to the development, manufacture, and distribution of safe and effective medical devices designed for critical patient care. They continuously review their products, processes, and customer comments to ensure products and services meet the highest level of expectations. Airon’s operations and products comply with all local, national, and international regulations including ISO 9001 and 13485 certification.

Airon’s portable and affordable products are utilized around the world in hospital and EMS environments. Products include: MACS CPAP system for hospital and EMS use; pNeuton model A transport ventilator with built-in CPAP for hospital use; pNeuton model S transport ventilator with built-in CPAP for EMS use; and their latest addition, the pNeuton mini transport ventilator with nCPAP.

 

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