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ABM Respiratory Care’s BiWaze Clear System receives FDA 510(k) clearance

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Medical technology firm ABM Respiratory Care has received 510(k) clearance for its BiWaze Clear System from the US Food and Drug Administration (FDA).

The new airway clearance system provides Oscillating Lung Expansion (OLE) therapy using a unique Dual Lumen Breathing Circuit.

Dual Lumen Breathing Circuit prevents escaping of the exhaled aerosol from the handset or breathing tube till it is filtered by a coaxial bacterial/viral filter.

Using the OLE therapy, the new system helps patients clear their airways and prevent or treat atelectasis.

It can also be utilised for the treatment of both acute and chronic respiratory conditions in the hospital, home, and long-term care environments.

BiWaze Clear System provides three therapies, including lung expansion, high frequency oscillation and nebulisation along with Aerogen Solo.

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 stated that the OLE therapy is used for clearing the secretions from the airways in respiratory condition patients such as bronchiectasis, cystic fibrosis, and neuromuscular conditions.

Hospitals have been using this therapy over a decade and it has also been proven to be an effective therapy to clear airways.

OLE therapy was found to decrease 31% of postoperative pulmonary complications and reduce the mean length of hospital stay by 1.6 days in a recent study that involved post-surgical patients.

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