Spiro Robotics Wins FDA Clearance for Spiro-VISTA

Spiro Robotics has secured 510(k) clearance from the FDA for Spiro-VISTA, a handheld system combining video laryngoscopy and steerable endotracheal tube navigation in a single platform. Announced on 1 July 2026, the clearance covers adult tracheal intubation in hospital settings, including both routine and difficult airway scenarios. Spiro Robotics claims Spiro-VISTA is the first commercially available handheld system to integrate visualisation and steerable tube delivery in one device.

Tracheal intubation is performed roughly 30 million times each year in the US, with an estimated 6 to 7 million cases classified as difficult. First-attempt failure carries real clinical risk, including oxygen desaturation, airway trauma, unplanned ICU admissions and hypoxic injury. Existing approaches typically require separate video laryngoscopy or flexible bronchoscopy systems, often needing additional equipment or a second operator. Spiro-VISTA has achieved a 100% first-pass success rate across more than 130 preclinical and clinical procedures, including a first-in-human study of 30 patients with anticipated difficult airways published in Anesthesia & Analgesia earlier this year.

The Spiro-VISTA combines a reusable core with single-use sterile disposables, engineered for use across operating rooms, intensive care units and emergency departments. Founder Vladimir Nekhendzy, MD, FASA framed the clearance as a step toward making image-guided intubation more accessible and reproducible. CEO Dimitri Sokolov positioned the milestone as the foundation of a scalable handheld robotics platform intended to expand beyond airway management. Commercial rollout is planned as a phased launch through selected academic medical centres and high-acuity hospitals during the second half of 2026.

The commercial signal here is category creation rather than incremental improvement. If Spiro-VISTA delivers on early clinical data at scale, it establishes a new integrated-workflow category in airway management that traditional video laryngoscopy and bronchoscopy suppliers will need to respond to. The wider platform ambition puts the company in early competition with established handheld robotics players across other image-guided procedures.

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