The Focalist robotic image-guided system assists clinicians’ aim in placing IV lines, delivering nerve blocks or otherwise accessing the organs and vasculature without additional specialized training. Following its FDA clearance in July 2025, its first procedures included the removal of kidney stones through minimally invasive nephrolithotomy.
Mendaera signed up as the first partner in the Butterfly Embedded technology licensing program, shortly after the developer’s debut in 2023, with a commercialization deal that included sharing the revenue of every combined unit sold.
“Ultrasound is fundamental to how Focalist sees and guides intervention, and Butterfly gives us a uniquely digital and programmable imaging platform to build on,” Mendaera co-founder and CEO Josh DeFonzo said in a statement. “Bringing Butterfly into our commercial platform expands access to precise, image-guided intervention today, while its software-defined architecture opens a path toward AI-enabled image interpretation and robotic action.”
The Focalist was first cleared for use with EchoNous’ Kosmos imaging probe, though its predetermined change control plan filed with the FDA left open the door for expansions to additional commercially available ultrasound systems.
“Mendaera is tackling a real problem in healthcare with a platform designed to expand access to procedural imaging, while reducing reliance on a limited group of highly specialized expertise,” said Butterfly President and CEO Joseph DeVivo. “We’re proud that this milestone not only extends Butterfly’s commitment to democratizing medical imaging but also marks our first Butterfly Embedded partner to commercialize — bringing our vision to life and demonstrating what Ultrasound-on-Chip can enable beyond traditional ultrasound.”
Related: Butterfly Network wins FDA clearance for gestational age AI ultrasound tool
Butterfly had also signed a five-year deal with Arbor Neuroscience, formerly known as Forest Neurotech, to employ its semiconductor-powered ultrasound with the latter’s brain-computer interfaces.
Arbor, part of Convergent Research, aims to deliver functional brain imaging and neuromodulation using ultrasound, measuring changes in blood flow and neural activity using a 8,960-element probe provided by Butterfly.
