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Spiro Robotics has received FDA 510(k) clearance for Spiro-VISTA, its handheld, dual image-guided robotic system designed to assist with tracheal intubation in adult hospital patients.
The Video Intubation System for Total Access (Spiro-VISTA) is indicated for both difficult and routine tracheal intubation procedures. It combines dual-image guidance, robotic precision, and a servo-controlled flexible endoscope with 360° articulation to improve visualization and navigation during airway management.
In the company's first-in-human study, Spiro-VISTA achieved a 100% first-attempt intubation success rate across 30 patients, with no device-related adverse events reported. Additional clinical studies are planned in critically ill and complex surgical patients.
CEO Dimitri Sokolov said:
"FDA clearance moves Spiro Robotics from development into commercial launch."
The company plans a limited commercial launch while preparing for a Series A financing and further development of its handheld robotic platform, which could be expanded to additional airway and endoscopic procedures in the future.
