First-in-Human Study of Robotic-Assisted IV Catheterization Completed

Hyperion Surgical Inc. announced the completion of the world’s first robotic-assisted intravenous (IV) catheterization using its Ivy robotic vascular access platform, which integrates advanced imaging, artificial intelligence, and robotic precision to enable a no-touch approach to IV placements.

Performed by Hyperion’s clinical team as part of a first-in-human (FIH) clinical study completed earlier this year, this procedure marks the first clinical use of a robotic-assisted system for peripheral IV catheterization—the most common invasive procedure in medicine, according to the company. More than 300 million IVs are placed annually in the United States.

“No patient should ever be stuck more than once to place an IV. It’s long past time that we recognized that difficult-to-stick patients need a different paradigm,” Hyperion Surgical Founder/CEO Eric Peterson said. “Completing our first-in-human study represents the culmination of years of engineering, design, and clinical collaboration. We believe robotic and AI-assisted vascular access has the potential to deliver new levels of consistency, confidence, and predictability for clinicians and patients.”

The Ivy platform addresses a long-standing clinical challenge—the high variability and failure rate in IV placementsⁱ—and is designed to place the actual catheter, not just the needle, into the blood vessel. The platform has the potential to improve IV therapy across emergency, inpatient, and outpatient care. The Ivy platform, unlike current technologies, is a semi-autonomous vascular access system that offers high-quality image guidance using direct, continuous visualization and AI vessel recognition, as well as robotic insertion and stabilization. Current handheld devices require significant psychomotor skills to continuously manually stabilize the ultrasound probe and needle. In contrast, Ivy holds the probe and needle for the user, as well as performing the actual catheter insertion without any user contact. This aims to enable a no-touch technique that has the potential to lower the cognitive and coordination demands for image-guided IV placements. Its portability, combined with rapid setup and procedure times, makes the Ivy platform highly scalable. 

“In some populations, difficult IV access can exceed 50% of patients. IV access is a daily challenge across all healthcare environments, with existing solutions facing limitations in reliability and consistency. It is also one of the most frustrating and painful experiences for millions of patients,” stated Graham Snyder, M.D., medical director of Medical Simulation Center, WakeMed Health and Hospitals. “Given the ubiquity of the problem, technologies that integrate imaging, automation, and robotics hold promise to not only improve the patient experience, but to achieve broad quality gains throughout the healthcare system.”

Following completion of the first-in-human study earlier this year, Hyperion is preparing to submit to the U.S. Food and Drug Administration (FDA) and is planning additional clinical evaluations to further assess the Ivy robotic vascular access platform’s extended capabilities. The company also expects to begin commercialization within the next 16 months.

“Achieving the world’s first robotic-assisted IV catheterization is a landmark milestone for our team and partners,” Dr. Peterson said. “It validates our vision that intelligent automation can make vascular access more predictable, efficient, and ultimately more humane. Patients getting stuck multiple times just to place an IV is completely unacceptable.”

Hyperion Surgical Inc. is a medical technology company developing advanced robotic and AI-enabled systems to bring precision, automation, and consistency to vascular access and interventional procedures. Based in Miami, the company’s aims to make vascular access safer, faster, and more reliable for clinicians and patients worldwide.

Reference
ⁱ Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted but unacceptable: peripheral IV catheter failure. J Infus Nurs. 2015 May-Jun;38(3):189-203. doi: 10.1097/NAN.0000000000000100. PMID: 25871866.