Flight Medical Innovations Ltd has received FDA 510(K) clearance for its Flight 60 ventilator integrated O2 mixer version, according to a company announcement.
In addition, the FDA also provided marketing clearance for three of Flight 60’s advanced ventilation modes: Minute Volume Guarantee, Tidal Volume Guarantee and B-LEV. Though recently approved in the US, the integrated O2 mixer and advanced modes have already been in use for some time outside the US, according to Flight Medical.
The Flight 60 line of versatile acute-to-home care ventilators is suitable for all patients, from pediatric to adult, featuring acute care capabilities and meeting highest ventilation requirements without compromising ventilator’s safety, independence and mobility.
“The Flight 60 electronically controlled integral O2 mixer allows accurate and safe O2 enrichment and eliminates the need for external mechanical air/oxygen entrainment mixer” said Mike Burshtine, Flight Medical’s CEO. “The advanced Volume Guarantee and B-LEV modes will further expand the use of Flight 60 ventilators in hospitals into the acute care wards. The 12-hour battery life, internal compressor, and low flow/high pressure oxygen enable moving patients from ICU to different care points inside and outside the hospital, keeping them on the same ventilator.”
“We have been continuously adding features, capabilities and flexibility to our Flight 60 line of ventilators and we will keep adding them to answer patients’ and caregivers’ needs and requests” added Burshtine.
Flight Medical Innovations Ltd. has been developing and manufacturing high-end portable ventilators for more than 15 years, for use in hospitals, long-term care facilities, home care, and Emergency Medical Services. More information is available on the company’s website.