Inovytec has announced that the FDA has granted FDA 510(k) clearance for its Ventway Sparrow ventilators.
The 2.2 lb. transport and emergency ventilators had previously won FDA emergency authorization for use during the COVID-19 public health emergency. They are already commercialized in Europe, Canada and Australia and are undergoing registration procedures in other countries, according to Ra’anana, Israel-based Inovytec.
The Ventway Sparrow transport and emergency ventilators are designed for mobility, high performance and ease of use, the company said in a news release. They allow for both invasive and noninvasive ventilation for patients weighing above 5 kg. (11 lb.). A built-in turbine removes the 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 models are designed to meet the needs and the standards set by various market segments:
- Ventway Sparrow enables emergency medical service workers to start ventilating anywhere, including land or air ambulances.
- Ventway MIL Standard is 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 is MRI-compatible and made for in-hospital use.
“Inovytec’s mission is to develop critical medical solutions that strengthen every step of the chain of survival,” said Inovytec CEO Udi Kantor in the release. “This important milestone allows our ventilators to aid healthcare providers in the U.S. 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.”