RT’s Three Key Takeaways:

  1. The BiWaze Clear system by ABM Respiratory Care received expanded FDA indication for in-line ventilator use in acute care settings.
  2. The system allows for oscillating lung expansion therapy aimed at addressing airway obstructions and improving gas exchange.
  3. Clinical data has shown positive outcomes, including a 64% decrease in ventilator time and a 47% reduction in post-operative pulmonary complications.

ABM Respiratory Care, a medical technology company focused on developing airway clearance and ventilation solutions, announced an expanded indication granted to the BiWaze Clear system. 

The oscillating lung expansion (OLE) therapy of BiWaze Clear is intended to remove airway obstructions caused by retained secretions in the lower airways, as well as re-expand collapsed areas of the lungs, prevent respiratory tract infections, and enhance gas exchange and oxygenation. 

BiWaze Clear has now received US Food and Drug Administration 510k clearance for use in-line with a ventilator in acute care environments.

BiWaze Clear on a mobile cart. Photo credit: ABM Respiratory Care

This presents acute care facilities with a therapeutic option for ventilated patients experiencing atelectasis, retained secretions, or pneumonia. The inclusion of OLE therapy in-line with ventilators has demonstrated positive outcomes, including a 64% decrease in ventilator time and a 47% reduction in post-operative pulmonary complications among intubated patients.

“This pivotal indication will greatly benefit our customers and patients,” says Greg Miller, CEO of ABM Respiratory Care, in a release. “The expanded use of BiWaze Clear with ventilators underscores our commitment to continuously enhance patient care and highlights the versatility of our BiWaze platform.”

BiWaze Clear initially received FDA 510k clearance in December 2022 for use with a face mask, mouthpiece, or trach adapter in acute and home care settings. 

Photo caption: BiWaze Clear

Photo credit: ABM Respiratory Care