Ventway Sparrow ventilators help to offer both invasive and noninvasive ventilation for patients weighing above 5kg
The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Medical devices maker Inovytec has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Ventway Sparrow line of ventilators.
The ventilators, which are already available in Europe, Canada and Australia, are undergoing registration procedures in other countries.
Designed for mobility, the Ventway Sparrow transport and emergency ventilators weigh only ~1kg and facilitate both invasive and noninvasive ventilation for patients weighing above 5kg.
A built-in turbine, which serves as a cooling system, helps to avoid dependence on external oxygen supply. The ventilator’s quick start mode enables ventilation to begin within five seconds after three click, while the internal battery offers up to 4.5 hours of operation.
Ventway Sparrow ventilators introduced in three variants
Inovytec is offering the ventilator in three variants that include Ventway Sparrow, Ventway MIL Standard and Ventway MRI.
The lightweight, internal turbine and small size features of the Ventway Sparrow allows to begin ventilating anywhere including land or air ambulances.
Ventway MIL Standard is a military-grade lightweight tactical ventilator that is night vision compatible and operational at altitudes of up to 25,000ft.
Ventway MRI is suitable for ICU and emergency department settings as well as surgeries, recovery rooms, and for patient transfers.
The ventilator has been selected to fight against Covid-19 epidemic in Italy, Spain, UK, South-Africa, Russia and Israel. It earlier secured emergency use authorisation from the US Food and Drug Administration (FDA).
Inovytec co-founder and CEO Udi Kantor said: “This important milestone allows our ventilators to aid healthcare providers in the US to safely and easily treat and transfer patients.
“We are confident that due to its ultra-portability, high-performance, ease of use and low maintenance needs, the Ventway family will aid medical staff in the field and during the transportation of ventilated patients.”
In December 2020, CorVent Medical secured FDA EUA status for the use of its RESPOND-19 Ventilator for primary critical care.