Israeli company ETView has been granted US FDA 510(k) clearance for an expanded size range of its VivaSight™-DL Airway Management System. The company currently distributes the VivaSight™-DL Airway Management System in the US.
ETView has pioneered development of the VivaSight™ platform, combining an airway ventilation tube with integrated continuous high resolution airway imaging for patient airway control and lung isolation capability.
In so doing the system eliminates the need for fiberoptic bronchoscope imaging during these procedures.
The newly expanded approval means the system will now be appropriate for use in all anatomical size variants.
ETView’s patented VivaSight™ airway management portfolio consists of single-use disposable medical devices, representing either single or double lumen ventilation tubes with an integrated continuous high resolution airway imaging system. VivaSight™-SL and VivaSight™-DL are currently sold in Europe, Israel, and the US to overcome current limitations and associated adverse surgical events during lung isolation surgeries.
“With this new 510(k) clearance, we are able to expand the range of VivaSight™-DL sizes available to the clinical community,” stated Bill Edelman, CEO. He continued, “We anticipate significant clinical interest for this innovative technology in the markets VivaSight™-DL is cleared for commercial distribution. With both VivaSight™-SL and VivaSight™-DL available in the US, ETView offers a complete airway management solution for 100% of lung-isolation surgeries. We look forward to additional regulatory clearances world-wide which will expand the market for our VivaSight™ portfolio.”
Source: ETView Medical, Ltd., Business Wire