ABM Respiratory Care, a company with offices in USA, Singapore, and India, announced that it has received FDA 510(k) clearance to market its BiWaze Cough System, a device for removing secretions in patients who are unable to cough or clear secretions effectively.
The BiWaze Cough System consists of a touch-screen device connected to a non-invasive suctioning mask. It is a portable alternative to the invasive and more involved process of upper airway suctioning. The system also provides high frequency oscillations, between 5-20 Hz, to break up thick secretions and facilitate their removal from the lungs.
The touch-screen device is about the size of notebook paper and weighs less than 9 pounds, including the battery. It also links to a mobile app, through which users can customize oscillation and other therapy settings to optimize the system for their particular needs. The device itself can store up to 20 different therapy profiles.
The BiWaze Cough System is important for patients with spinal cord injuries or neuromuscular deficits, according to the company. In these patients, suppressed ability to cough results in inability to clear respiratory tract secretions, which could block the airway and could result in pneumonia if aspirated.
“Receiving our first FDA 510(k) clearance is a great achievement for the company,” said Vinay Joshi, ABM CEO, in a statement. “We can now focus on executing our corporate strategy of integrating additional respiratory therapies into our BiWaze platform system and providing a truly novel approach to respiratory care.”
Product page: BiWaze Cough