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On September 11, 2025, surgical robotics startup Mendaera announced that its Focalist handheld surgical robot system completed the world’s first clinical application at the Mayo Clinic in the United States. The system was operated by urologist Dr. Karen Stern and applied in percutaneous nephrolithotomy (PCNL), officially announced at the World Congress of Endourology and Technology (WCET). This milestone case marks an important exploration of surgical robots in the direction of “handheld and lightweight”.
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Clinical Application ScenarioPCNL is the “gold standard” procedure for treating large kidney stones, with the primary step being to accurately place a puncture needle into the kidney under imaging guidance, thereby establishing a channel for stone removal. This step requires extremely high precision: on one hand, it needs to avoid surrounding organs, and on the other hand, it must achieve a successful puncture in the ideal position on the first attempt; otherwise, it increases the risk of complications and surgical difficulty.During the surgery at the Mayo Clinic, Dr. Stern used the Focalist system to complete the puncture. The system’s handheld mechanical structure combined with real-time ultrasound imaging made the needle path positioning more intuitive, allowing the team to achieve a quick and precise single-entry approach. She stated after the conference that the Focalist is intuitive to use and easy to integrate into existing workflows, especially helping less experienced doctors build confidence and improve the success rate of ultrasound-guided punctures.
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System Features and Company ProgressThe Focalist is an integrated system combining a handheld robot, real-time ultrasound imaging, and advanced software algorithms, specifically designed to assist surgeons or interventionalists in needle path or instrument placement under ultrasound guidance.System Features
- Handheld design: Unlike traditional large surgical robots that are bulky and heavy, the Focalist is closer to the feel of a handheld probe operated by doctors, making it more portable and flexible.
- Real-time ultrasound feedback + visual software guidance: The system collaborates with the probe, allowing doctors to view ultrasound images while receiving system assistance in locating and aligning the needle path.
- Precision and repeatability: Supports “first-pass” accurate entry, reducing the need for errors and repeated adjustments.
- Friendly learning curve: In the news, Dr. Stern mentioned that the system is “intuitive and easy to learn,” making it easy to integrate into existing operational processes, particularly enhancing confidence for less experienced operators.
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Company Progress
- FDA Approval: Focalist received 510(k) certification from the US FDA in July 2025 for instrument/needle placement under ultrasound guidance.
- Usage and Release Plan: The company will start with urology (such as PCNL) and plans a limited launch in some medical institutions in the US in 2025, with an expected expansion to other specialties in 2026.
- Cooperation Background: Collaborating with Cook Medical to advance needle path robotic intervention technology.
- Indicators / Functional Details: The system includes touchscreen targeting, robotic needle positioning, and continuous needle depth tracking functionalities.
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MedRobot ObservationsThe emergence of Focalist represents a “lightweight” attempt in the development path of surgical robots. Unlike traditional large, multi-joint platforms, it focuses on a critical step in the surgical process—establishing the needle path—and achieves precision and repeatability through a handheld robot and real-time ultrasound. This “focused small incision” approach lowers the threshold for clinical entry of the device and may help more doctors, especially young and grassroots doctors, overcome the learning curve and improve puncture success rates.For the industry, the insight brought by Focalist is that not all surgical robots need to be “all-rounders”; instead, there may be more specialized robots targeting specific steps in the future. They are smaller, cheaper, and have shorter learning curves, allowing them to find a foothold in certain clinical scenarios before gradually expanding.Of course, such products also face challenges:
- Will the market be willing to pay for a “single-function robot”?
- How will hospital procurement and insurance payments keep up?
- Can it expand to more departments beyond urology, such as gastroenterology, respiratory, and interventional?
These remain to be validated. But it is certain that Mendaera’s attempt has broadened the boundaries of the concept of “robotics,” no longer limited to large platforms like the Da Vinci, but more like an “intelligent surgical tool.”# MedRobot Recommended Article Collection
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