Spiro Robotics earns FDA clearance for image-guided system for tracheal intubation

Spiro Robotics earned FDA 510(k) clearance for its handheld, dual image-guided system for tracheal intubation, Spiro-VISTA.

Clearance authorizes Spiro-VISTA (Video Intubation System for Total Access) to be used as an aid in placing an endotracheal tube during difficult and non-difficult tracheal intubation procedures in adult hospital patients, the company said.

“FDA clearance moves Spiro Robotics from development into commercial launch,” Spiro Robotics CEO Dimitri Sokolov said in a news release. “Our focus now is disciplined execution: limited commercial release, additional clinical studies, and preparation for a Series A financing to further advance commercialization, clinical expansion, and our broader handheld platform strategy.”

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