ABM Respiratory Care, a medical technology company focused on developing and commercializing integrated airway clearance and ventilation solutions, has received U.S. FDA 510(k) clearance of its BiWaze Clear System.

This new airway clearance system helps patients clear their airways as well as prevent or treat atelectasis by using oscillating lung expansion (OLE) therapy. BiWaze Clear can be used to treat both acute and chronic respiratory conditions in the hospital, long-term care, and home environments.

OLE therapy is a treatment used to help clear secretions from the airways in people with respiratory conditions such as cystic fibrosis, bronchiectasis, and neuromuscular conditions. It has been utilized in the hospitals for over a decade and has been proven to be an effective airway clearance therapy. In fact, a recent study involving post-surgical patients demonstrated that OLE therapy decreased postoperative pulmonary complications by 31% and shortened the mean length of stay in the hospital by 1.6 days.

The BiWaze Clear system is portable and can be used anywhere, thanks to its lightweight and battery-powered design, company officials say It delivers OLE therapy using a unique Dual Lumen Breathing Circuit, which prevents exhaled aerosol from escaping the handset or breathing tube until it is filtered by a coaxial bacterial/viral filter. BiWaze Clear delivers three therapies: lung expansion, high frequency oscillation and nebulization with the Aerogen Solo.

“We are continuing to expand our portfolio of respiratory care products to help more people with our technologies,” says Vinay Joshi, CEO of ABM Respiratory Care. “The BiWaze Clear System has been designed to help prevent the spread of bacterial and viral infections like COVID-19. We are proud to introduce this innovative OLE therapy system.”

Featured image: BiWaze Clear System. Photo: ABM Respiratory Care