ABM Respiratory Care Announces The Fda Clearance Of The Biwaze Clear System

EAGAN – ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel integrated airway clearance and ventilation solutions, announced today the U.S. Food and Drug Administration (FDA) 510(k) clearance of the 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 hospitals for over a decade and has been proven to be an effective airway clearance therapy. 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 1.

The innovative BiWaze® Clear system is portable and can be used anywhere, thanks to its lightweight and battery-powered design. 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,” said the CEO of ABM Respiratory Care, Vinay Joshi. “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.”

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