Inovytec receives FDA clearance for ventilator products
Inovytec, multi-functional critical medical devices developer has been granted FDA 510(k) clearance to market and sell its Ventway Sparrow ventilators in the United States.
The ventilators are already commercialised in Europe, Canada and Australia and undergoing registration procedures in other countries.
The Ventway Sparrow transport and emergency ventilators are designed for mobility, high-performance and ease of use. They weigh approximately 1kg and allow for both invasive and non-invasive ventilation for patients weighing above 5kg. A built-in turbine removes dependency from external oxygen supply and serves as a cooling system, while an optional quick start mode allows for ventilation to start within five seconds after three clicks. An internal battery provides up to 4.5 hours of operation.
Three different Ventway Sparrow models are designed to meet the needs and the standards set by various market segments:
- Ventway Sparrow: Features a lightweight, internal turbine and small size to start ventilating anywhere including land or air ambulances.
- Ventway MIL Standard: A military-grade lightweight tactical ventilator that is more robust, night vision compatible and operational at altitudes of up to 25,000 feet.
- Ventway MRI: MRI compatible and made for in-hospital use, the Ventway MRI can be used in ICU and emergency department settings as well as surgeries, recovery rooms, and for patient transfers.
It has been chosen also for fighting COVID-19 epidemic in Italy, Spain, UK, South-Africa, Russia and Israel and had previously been cleared for use in the United States under FDA Emergency Use Authorization.
Udi Kantor, co-founder and CEO of Inovytec, said: “Inovytec’s mission is to develop critical medical solutions that strengthen every step of the chain of survival. 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.”