Line of Airway Devices Receives FDA Clearance

The U.S. Food and Drug Administration has granted 510(k) clearance to ETView for its VivaSight-DL line of airway devices. The line is expected to enter the United States market immediately, and the company also expects pre-market regulatory clearances in Europe and Asia this year.

The VivaSight-DL is a proprietary, single-use disposable medical device, consisting of a dual lumen airway ventilation tube with an integrated continuous high-resolution video airway imaging system intended to permit airway control and lung isolation during certain surgical procedures. Lung isolation is employed to provide one-lung ventilation in patients undergoing thoracic, cardiac, vascular, or esophageal surgeries. During lung isolation, temporary visualization of the patient airway is achieved with a fiber optic bronchoscope while the patient is ventilated and the target lung isolated. Intra-operative surgical maneuvers often require repeated imaging and partial blocking of the airway to maintain lung isolation. It is estimated that over 1.9 million lung isolation procedures are conducted worldwide annually, accounting for over $250 million in single-use medical disposables.

The VivaSight platform combines an airway ventilation tube with integrated continuous high resolution airway imaging for patient airway control and lung isolation capability, which ETView claims eliminates the need for fiber optic bronchoscope imaging during such procedures.

“We are excited to have reached this milestone,” said ETView CEO Bill Edelman of FDA clearance. “We anticipate significant clinical interest for this innovative technology in the markets where VivaSight-DL is cleared for commercial distribution. With both VivaSight-SL and VivaSight-DL available in the U.S., ETView can now offer a complete airway management solution for 100 percent of lung-isolation surgeries. We look forward to additional regulatory clearances world-wide which will expand the market for our VivaSight portfolio.”

Based in Tel-Aviv, Israel, ETView Medical Ltd. specializes in devices such as VivaSight that combine airway management with airway visualization for physicians.