Singapore-based medical device start-up ABM Respiratory Care has received the US Food and Drug Administration (FDA) 510(k) approval for its BiWaze Clear System.
The new airway clearance system leverages Oscillating Lung Expansion (OLE) therapy to help patients clear their airways, along with preventing or treating atelectasis.
OLE therapy works to clear secretions from the airways in people with respiratory conditions including cystic fibrosis, bronchiectasis, and neuromuscular conditions.
BiWaze Clear can be used to treat both acute and chronic respiratory conditions in the hospital, long-term care, and home environments, said the company.
ABM Respiratory Care CEO Vinay Joshi said: “We are continuing to expand our portfolio of respiratory care products to help more people with our technologies.
“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.”
The company said that its BiWaze Clear system delivers three therapies for lung expansion, high-frequency oscillation, and nebulisation with the Aerogen Solo.
Its lightweight and battery-powered design make it a portable device, that delivers OLE therapy using a unique Dual Lumen Breathing Circuit.
The advanced breathing circuit is said to prevent the exhaled aerosol from escaping the breathing tube until a coaxial bacterial or viral filter filters it.
ABM Respiratory Care said that hospitals have been using OLE therapy for more than a decade and has been proven to be an effective airway clearance therapy.
In a recent study, OLE therapy decreased postoperative pulmonary complications by 31% and shortened the mean length of stay in the hospital by 1.6 days.
Established in 2017, ABM Respiratory Care is a medical technology company focused on novel integrated airway clearance and ventilation solutions.
The company’s connected respiratory therapy platform facilitates deeper breathing, improved oxygen exchange, reduce aerosol emission exposure, and communication.
