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Spiro Robotics has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Spiro-VISTA (Video Intubation System for Total Access), a handheld system that combines video laryngoscopy with steerable navigation for tracheal intubation.
The clearance authorizes Spiro-VISTA for use as an aid in placing an endotracheal tube during both non-difficult and difficult tracheal intubation procedures in adults in hospital settings. According to the company, the device is the first commercially available handheld system to integrate video laryngoscopy and steerable endotracheal tube delivery into a single platform.
Spiro Robotics is developing a handheld robotics platform that combines imaging, navigation, precision control and physical AI, initially focusing on airway management before expanding into additional image-guided minimally invasive procedures.
Tracheal intubation is performed approximately 30 million times each year in the United States, with an estimated 6 to 7 million cases classified as difficult. First-attempt failure during these procedures can result in complications including oxygen desaturation, airway trauma, unplanned intensive care admissions and, in severe cases, hypoxic injury or death.
Conventional approaches to managing difficult airways often rely on separate video laryngoscopy or flexible bronchoscopy systems, which may require additional equipment, specialist training or a second operator. Spiro-VISTA combines visualization and steerable tube delivery into a single handheld device, enabling a single clinician to perform the procedure with an integrated workflow.
Spiro Robotics reports that Spiro-VISTA achieved a 100% first-pass success rate across more than 130 preclinical and clinical procedures.
The company’s first-in-human study, involving 30 patients with anticipated difficult airways and published in Anesthesia & Analgesia in 2026, reported a 100% first-attempt intubation success rate with no adverse events. Earlier preclinical evaluations in more than 100 human cadavers also achieved first-pass success across a range of challenging airway scenarios, including Grade 3 and Grade 4 views, lateral and prone positioning, and contaminated airways.
Commenting on the milestone, Vladimir Nekhendzy, MD, FASA, Founder of Spiro Robotics, said:
“FDA clearance is an important milestone in our mission to make image-guided intubation more accessible, controlled, and reproducible for clinicians managing both difficult and routine airways. We are grateful to the investigators, advisors, team members, and investors who helped bring Spiro-VISTA from concept to clearance.”
Dimitri Sokolov, Chief Executive Officer of Spiro Robotics, added:
“FDA clearance marks the transition from innovation to commercialization and establishes the foundation for a scalable handheld robotics platform designed to transform image-guided procedures across medicine.”
The system combines a reusable core with single-use sterile disposable components, supporting use in operating rooms, intensive care units and emergency departments. Spiro Robotics says this approach is intended to bring image-guided robotic technology into routine airway management while maintaining a practical workflow for healthcare providers.
The company plans to introduce Spiro-VISTA through a phased commercial launch with selected academic medical centres and high-acuity hospitals during the second half of 2026.
Commenting on the potential impact of the technology, Dr. Edward Damrose, Professor of Otolaryngology-Head and Neck Surgery at Stanford University, said:
“Spiro-VISTA’s tracheal intubation platform is truly revolutionary. It presents a highly competitive, cost-effective solution for hospitals, offering potential savings through cost avoidance and operational efficiency.”
Innovations in robotics, AI-assisted procedures and image-guided technologies will be among the topics explored at MedTech World Asia 2026, taking place in Hong Kong from 26–28 August. The event will bring together healthcare leaders, innovators, investors and clinicians to discuss the latest developments in medical technology across Asia and beyond. Book your spot now.
