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.”
Spiro Robotics said that despite improvements in intubation technology, clinicians still face blind spots in difficult airways and lack active control of intubation.
“Difficult or failed tracheal intubation remains a major cause of poor patient outcomes, including severe hypoxia, airway trauma, ICU admission, and in the most severe cases, brain damage, hypoxic injury or death,” the company said in a news release.
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Spiro-VISTA provides clinicians with a “fully integrated and actionable approach to airway management regardless of difficulty” with dual image guidance, precise controls, navigation and tube delivery. Its flexible endoscope is servo-controlled and provides robotic precision with 360° articulation and maneuverability, the company said.
In its first-in-human study, Spiro-VISTA achieved 100% successful first-attempt intubation in all 30 patients in the study with no adverse events reported during device use, Spiro Robotics said.
Additional clinical studies are planned to evaluate Spiro-VISTA in critically ill and complex surgical patients where airway management is often high-risk and operationally complex, according to Spiro.
Spiro Robotics said the system was designed as a scalable platform and it may also integrate future advancements in computer-assisted guidance and precision targeting of the vocal cords during airway management. The company also said the handheld platform could potentially support broader applications in airway and endoscopic procedures.
The recently FDA-cleared system is one of the affordable, handheld robotic platforms the company is developing with physical AI that combines advanced imaging, navigation and precision control. Spiro Robotics says it’s beginning with platforms for airway management and plans to expand into additional minimally invasive procedures.
