Respiratory care device developer Ventec Life Systems said today it won FDA 510(k) clearance for its VOCSN portable life support device.
The VOCSN device provides 5 different respiratory therapies, including ventilation, oxygen, cough, suction and nebulization. The Bothell, Wash.-based company claims it is the only device cleared by the FDA which provides all 5 respiratory therapies.
The device is cleared for use with adults and pediatric patients weighing more than 5 kg, the company said, and is designed to improve care for patients with neuromuscular diseases, impaired lung function, spinal cord injuries and pediatric development complications.
Ventec claims the device is 70% lighter and smaller than existing machines, and features a 9-hour on-board battery controlled through a touch screen interface.
“I’ve seen firsthand how improved ventilator technology can enhance the quality of life for patients and caregivers. Our team didn’t want to create just another ventilator, we spent the past 5 years focused on building a truly integrated solution,” founder & CEO Doug DeVries said in a press release.