Mendaera has claimed an FDA clearance for its handheld robotic needle delivery system, for precision placement guided by ultrasound imaging.
The recent Fierce Medtech Fierce 15 winner aims to tap into some of the most common medical procedures performed today—about 200 million per year—by bringing a new category of robotics to tasks such as the insertion of centralized catheters into major blood vessels, performing fine needle aspiration biopsies and providing local doses of medications and anesthetics.
The Silicon Valley-based company’s Focalist system weighs about as much as a mobile phone and clips onto a handheld ultrasound probe to read its imaging feed. The touchscreen device gives the user a green light when the needle is correctly aligned with its target and ready to push, while tracking its depth.
Mendaera said it will start with a limited commercial launch this year—beginning with a focus on urology, such as procedures to remove larger kidney stones through the skin—before expanding nationwide to other medical specialties in 2026.
“Our mission is to ensure that these procedures are delivered safely and efficiently across the healthcare system by enabling more providers with the confidence needed to perform these techniques,” Mendaera co-founder and CEO Josh DeFonzo said in a statement. “Robotics have been shown to increase provider capabilities in complex procedures, and we intend to demonstrate that the same can be true in everyday care.”
In previous studies comparing the robot’s performance to freehanded needle attempts, the company said the Focalist system improved first-stick accuracy for every user, ranging from trained specialists to beginners with little clinical experience.
“We expected improvements in users regardless of their baseline skill,” DeFonzo said in an interview with Fierce earlier this year. “What we did not expect … was that while everyone was better, novices were better using our product than even interventional radiologists and emergency medicine specialists, who do this all day.”
Looking ahead, the company plans to develop artificial intelligence programs that could automatically highlight anatomy, such as a particular artery. Mendaera is also working on providing telehealth connectivity, which would allow a specialist to remotely observe and guide needle placements by front-line clinicians.
Last September, Mendaera raised $73 million in venture capital funding through a series B round led by Threshold Ventures. Additional backers included Lux Capital, PFM Health Sciences and Frederic Moll, founder of Intuitive Surgical and Auris Health.