Mendaera said on October 1 that its Focalist handheld robot now works with a customized Butterfly Network iQ3 probe. Focalist guides needles for vascular access, regional nerve blocks and organ access, and FDA cleared it through a 510(k) in July 2025. The first applications were minimally invasive kidney stone procedures.
The two companies first signed in 2023 under Butterfly's Embedded program, which licenses the Ultrasound-on-Chip to third parties building their own devices. The deal includes revenue sharing on combined unit sales. Mendaera is the first Embedded partner to reach the market. Focalist launched on the EchoNous Kosmos probe, and the change control plan Mendaera filed with FDA allowed it to add imaging systems later.
That change control plan is the part worth copying. Writing future imaging suppliers into the original submission turns a component swap into a documentation exercise rather than a second clearance, which is the difference between shipping this quarter and shipping next year. Mendaera closed a $73M Series B led by Threshold Ventures in September 2024 and is based in San Mateo, California.