Inovytec's Ventway Sparrow Line of Ventilators Receives FDA 510(k) Clearance to Market
The High-Performance Ventilators Weigh Only ~1kg (2.2 Pounds) and Include Product Lines for EMS, Military and Hospitals
02 Feb, 2021, 09:00 ET
RA'ANANA, Israel, Feb. 2, 2021 /PRNewswire/ -- Inovytec, an innovator of multi-functional and user-friendly critical medical devices, announced today that it was granted FDA 510(k) clearance to market and sell its Ventway Sparrow ventilators in the United States. The ventilators are already commercialized 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 only ~1 kilogram (2.2 pounds) and allow for both invasive and noninvasive ventilation for patients weighing above 5 kg. 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: EMS can take advantage of the 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.
"Inovytec's mission is to develop critical medical solutions that strengthen every step of the chain of survival," said Udi Kantor, Co-founder, and CEO of Inovytec. "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."
Inovytec's family of innovative medical solutions address the critical moments of care, from the first minutes after a medical event to patient transfers and stabilization in hospitals. SALI creates a virtual hospital environment in the field and allows for citizens to act as first responders during critical emergencies from first aid to resuscitation with on-line communication to a remote medical center. Ventway is the most portable advanced ventilator system available, with specialty ventilators for the hospital, military, EMS and soon homecare mobility environments. Lubo is a first-line airway management tool for EMS teams and first responders, which also includes neck stabilization for trauma patients. Each product's goal is to strengthen the healthcare continuum in the chain-of-survival and improve outcomes in both routine and emergency medical events. The company was founded in 2011.
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