Mendaera earns FDA clearance for Focalist handheld robotic system

Mendaera Inc. at the moment introduced that it has obtained U.S. Meals and Drug Administration 510(ok) clearance for its Focalist handheld robotic system. The San Mateo, Calif.-based firm mentioned it designed Focalist to simplify and improve the precision of ultrasound-guided needle placement — a technically demanding process carried out throughout many specialties and care settings.

“Exact placement of needles to carry out a variety of procedures — organ entry, biopsies, vascular entry, or remedy supply, as examples — is a really difficult however foundational method that underpins most affected person care journeys,” acknowledged Josh DeFonzo, co-founder and CEO of Mendaera.

“Our mission is to make sure that these procedures are delivered safely and effectively throughout the healthcare system by enabling extra suppliers with the boldness wanted to carry out these strategies,” he added. “Robotics have been proven to extend supplier capabilities in advanced procedures, and we intend to show that the identical may be true in on a regular basis care.”

Mendaera claimed that it is constructing a brand new class of handheld robotics to make precision surgical procedure extra accessible throughout healthcare. The San Mateo, Calif.-based firm is backed by main buyers and mentioned its management staff has been profitable in taking medical know-how firms startups to profitable exits, equivalent to Auris Well being.

In September 2024, Mendaera raised $73 million in Sequence B funding. Threshold Ventures led the funding spherical. Lux Capital, PFM Well being Sciences, and Fred Moll, the founding father of Intuitive Surgical and Auris Well being, additionally participated within the spherical.

Mendaera targets frequent however troublesome procedures

Picture-guided procedures involving the position of needles or different interventional devices are a cornerstone of medical care. They’re utilized in tons of of hundreds of thousands of affected person encounters globally every year.

Regardless of being commonplace, the success of those procedures is extremely depending on the operator’s coordination, spatial judgment, and expertise, famous Mendaera. These expertise are arduous to amass and fluctuate considerably throughout suppliers and establishments, resulting in inconsistent affected person experiences and system-wide inefficiencies, it mentioned.

The corporate mentioned it designed Focalist to assist exact and constant needle placement throughout a breadth of customers and scientific settings. The system integrates handheld management, real-time ultrasound imaging, and superior software program. The robotic additionally options touchscreen concentrating on, robotic needle positioning, and steady needle depth-tracking to allow reproducible minimally invasive procedures.

“Simplifying ultrasound-guided percutaneous entry is among the most impactful methods to enhance effectivity, security, and independence in urology and past,” mentioned Dr. Gerhard J. Fuchs, professor of scientific urology on the College of Southern California. “Ultrasound steerage gives the advantages of diminished radiation and higher visualization of key anatomy, and when paired with robotics, can decrease the barrier to specific entry and instrument placement.”

“Mendaera’s platform represents a significant evolution — one with the potential to broaden entry to minimally invasive procedures and elevate the usual of care,” he mentioned.

Focalist proceeds towards commercialization

The FDA has cleared Mendaera’s Focalist system to be used within the U.S. in diagnostic or therapeutic procedures with pediatric and grownup sufferers.

With the clearance, Mendaera is beginning a restricted launch of Focalist with choose medical establishments this yr. This launch will initially concentrate on makes use of in urology, equivalent to supporting procedures like percutaneous nephrolithotomy (PCNL), the place exact entry to the kidney is required.

The firm plans to later increase to different specialties. Mendaera mentioned it anticipates full commercialization of the Focalist system in 2026.