Research & Development
ABM Respiratory awarded FDA 510(k) clearance for BiWaze Cough System to clear secretions in people unable to cough
1 April 2020 -

Medical device company ABM Respiratory care reported on Tuesday the receipt of US FDA 510(k) clearance to market its innovative BiWaze Cough system that helps remove secretions for people unable to cough or clear secretions effectively due to reduced peak cough flow resulting from high spinal cord injury, neuromuscular deficits or severe fatigue associated with intrinsic lung disease.

The company added that the BiWaze Cough system is the smallest and lightest assisted cough device on the market. The low profile design and touch screen navigation offers a user friendly experience. The non-invasive solution clears secretions from the upper airways as compared to invasive suctioning as well as provides high frequency oscillations to break up thick secretions and help remove them from the lungs.

Each therapy cycle can be personalized to provide the most effective therapy for a person's respiratory condition, disclosed the company.

In addition, the cough device leverages an unique BiWaze platform engine that has two separate paths and blowers for managing inhale and exhale breaths, which is unlike any other cough device on the market. The BiWaze engine provides an improved control of the airflow through the device and efficient oscillations in all phases of therapy, concluded the company.



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