BioMedInnovations announced today that it received FDA emergency use authorization (EUA) for its SuppleVent ventilator technology.
With the EUA, the SuppleVent system becomes the latest alternative ventilator to gain some form of authorization to assist during the COVID-19 pandemic.
Denver, N.C.-based BioMedInnovations’ proprietary back-pressure regulator (BPR) technology was designed in collaboration with Lawrence Livermore National Laboratory (LLNL) and partners Equilibar Precision Pressure Control and Roush Yates Manufacturing Solutions.
SuppleVent includes a clinician-friendly interface with full alarms and low power operation from a compressed gas source, along with forward flexibility in the architecture to add displays, data logging, wireless communication, closed-loop control and other features.
The ventilator accepts 50psi compressed air or oxygen mix and is powered by a110V/220V AC outlet or optional DC battery supply, according to a news release. Its design accommodates a standard 22mm ventilator circuit with either a mask or an endotracheal tube.
“BMI is pleased with the FDA’s decision, which underscores the applicability of the core technology in our organ perfusion system,” BioMedInnovations CEO Sherif Gabriel said in the release. “In partnership with Lawrence Livermore National Laboratory, we were able to quickly design a machine with minimal components that is easy to assemble in an effort to help COVID-19 patients and healthcare providers who are in need of highly efficient, value-added ventilators.”
“This effort has been truly collaborative, and we are honored to have partners such as Roush Yates Manufacturing Solutions ready to quickly manufacture as many as 1,000 of these potentially life-saving machines per week,” added BioMedInnovations COO Carrie DiMarzio.