GE Healthcare, in partnership with Deep Breeze, a provider of vibration response imaging (VRI) technology, has received FDA 510(k) marketing clearance for the VRIxv, a non-invasive, radiation-free lung imaging system.
GE and Deep Breeze said that they designed the VRIxv to display information during the respiratory process on ventilated patients. The VRIxv records lung sounds by utilizing acoustic sensors brought in contact with the patients’ back while lying in bed. The software converts signals into images of the lungs with regional distribution maps, numerical representation and breathing graphs. Each recording samples 20 seconds of lung sounds, typically covering several breath cycles.
“The FDA clearance of VRIxv advances our efforts to create a new clinical paradigm in which our VRI technology will be the standard application in a broad line of clinical applications, such as monitoring the impact of ventilator settings or managing risk associated with mechanically ventilated patients.” said David Barton, president of the Or-Akiva, Israel-based Deep Breeze.