September 15, 2025
Mendaera , a healthcare technology company developing next-generation robotics technology to simplify ultrasound-guided needle procedures, today announced the world’s first procedures performed with the Focalist handheld robotic system. Urologist Karen Stern, MD, (Mayo Clinic Arizona) successfully used Focalist to achieve precise kidney access during percutaneous nephrolithotomy (PCNL), the gold standard treatment for large kidney stones. Dr Stern presented the milestone procedures at the World Conference on Endourology and Uro-Technology (WCET), a prestigious global meeting for surgeons advancing minimally invasive kidney stone treatment. PCNL begins with the placement of a needle into the kidney under imaging guidance, creating a pathway for stone removal. This critical first step requires extreme precision to avoid surrounding organs and to enable optimal and effective stone clearance. Using Focalist, Dr Stern and her team achieved rapid, efficient, and precise first-pass needle placement into the ideal kidney location. Dr Stern says: “I was thrilled to be the first in the world to use the Focalist System. I found it intuitive to learn and easy to integrate into my workflow. “Focalist enhances needle control and simplifies precise placement under ultrasound, particularly for operators with less experience. It has the potential to build confidence in ultrasound-guided access and lower the barrier to proficiency across providers with varying levels of experience.”
The Focalist System combines handheld robotics, real-time ultrasound, and advanced software to enable precise, repeatable instrument placement. These first-in-the-world procedures mark the beginning of the limited US launch of Focalist in urology, with expansion to additional specialties planned in 2026. Josh DeFonzo, co-founder and CEO of Mendaera, says: “These first procedures underscore Focalist’s ability to deliver highly precise, consistent needle placement – a foundational requirement across all of medicine. “We’re proud to partner with Dr Stern as she pioneers ultrasound-guided access in urology. We believe Focalist will empower more healthcare providers to perform procedures with confidence. This milestone brings us closer to our mission of broadening access to minimally invasive procedures and elevating standards across the healthcare system.”
The recorded case presentation by Dr Stern will be available in the coming weeks on the WCET website . Share this:

Mendaera undertakes first surgical procedures with Focalist handheld robotic system

SAN MATEO, Calif., September 12, 2025 — Mendaera™, Inc., a healthcare technology company developing next-generation robotics technology to simplify ultrasound-guided needle procedures, today announced the world’s first procedures performed with the Focalist™ handheld robotic system. Urologist Karen Stern, M.D., (Mayo Clinic Arizona) successfully used Focalist to achieve precise kidney access during percutaneous nephrolithotomy (PCNL), the gold standard treatment for large kidney stones. Dr. Stern presented the milestone procedures at the World Conference on Endourology and Uro-Technology (WCET), a prestigious global meeting for surgeons advancing minimally invasive kidney stone treatment. PCNL begins with the placement of a needle into the kidney under imaging guidance, creating a pathway for stone removal. This critical first step requires extreme precision to avoid surrounding organs and to enable optimal and effective stone clearance. Using Focalist, Dr. Stern and her team achieved rapid, efficient, and precise first-pass needle placement into the ideal kidney location. “I was thrilled to be the first in the world to use the Focalist System,” said Dr. Stern. “I found it intuitive to learn and easy to integrate into my workflow. Focalist enhances needle control and simplifies precise placement under ultrasound, particularly for operators with less experience. It has the potential to build confidence in ultrasound-guided access and lower the barrier to proficiency across providers with varying levels of experience.”
The Focalist™ System combines handheld robotics, real-time ultrasound, and advanced software to enable precise, repeatable instrument placement. These first-in-the-world procedures mark the beginning of the limited U.S. launch of Focalist in urology, with expansion to additional specialties planned in 2026. “These first procedures underscore Focalist’s ability to deliver highly precise, consistent needle placement – a foundational requirement across all of medicine,” said Josh DeFonzo, co-founder and CEO of Mendaera. “We’re proud to partner with Dr. Stern as she pioneers ultrasound-guided access in urology. We believe Focalist will empower more healthcare providers to perform procedures with confidence. This milestone brings us closer to our mission of broadening access to minimally invasive procedures and elevating standards across the healthcare system.”

Mendaera Announces World’s First Procedures with Focalist Handheld Robotic System

Mendaera™, Inc., a healthcare technology company developing next-generation robotics technology to simplify ultrasound-guided needle procedures, today announced the world's first procedures performed with the Focalist™ handheld robotic system. Urologist Karen Stern, M.D., (Mayo Clinic Arizona) successfully used Focalist to achieve precise kidney access during percutaneous nephrolithotomy (PCNL), the gold standard treatment for large kidney stones. Dr. Stern presented the milestone procedures at the World Conference on Endourology and Uro-Technology (WCET), a prestigious global meeting for surgeons advancing minimally invasive kidney stone treatment.  This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250911092227/en/  Focalist™ Handheld Robotic System  PCNL begins with the placement of a needle into the kidney under imaging guidance, creating a pathway for stone removal. This critical first step requires extreme precision to avoid surrounding organs and to enable optimal and effective stone clearance. Using Focalist, Dr. Stern and her team achieved rapid, efficient, and precise first-pass needle placement into the ideal kidney location.  “I was thrilled to be the first in the world to use the Focalist System,” said Dr. Stern. “I found it intuitive to learn and easy to integrate into my workflow. Focalist enhances needle control and simplifies precise placement under ultrasound, particularly for operators with less experience. It has the potential to build confidence in ultrasound-guided access and lower the barrier to proficiency across providers with varying levels of experience.”  The Focalist™ System combines handheld robotics, real-time ultrasound, and advanced software to enable precise, repeatable instrument placement. These first-in-the-world procedures mark the beginning of the limited U.S. launch of Focalist in urology, with expansion to additional specialties planned in 2026.  “These first procedures underscore Focalist's ability to deliver highly precise, consistent needle placement - a foundational requirement across all of medicine,” said Josh DeFonzo, co-founder and CEO of Mendaera. “We're proud to partner with Dr. Stern as she pioneers ultrasound-guided access in urology. We believe Focalist will empower more healthcare providers to perform procedures with confidence. This milestone brings us closer to our mission of broadening access to minimally invasive procedures and elevating standards across the healthcare system.”  The recorded case presentation by Dr. Stern will be available in the coming weeks on the WCET website  About Mendaera  Mendaera is building a new category of handheld robotics designed to make precision more accessible across healthcare. With its Focalist™ System, combining real-time imaging with intuitive handheld robotic control, Mendaera supports clinicians in delivering consistent, high-quality care across a broad range of minimally invasive procedures and settings. Based in Silicon Valley, CA, the company is backed by leading investors and a leadership team with a track record of successful outcomes, including Auris Health.  Mendaera's Focalist™ System has FDA clearance in the U.S. to provide guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and resulting image during diagnostic or therapeutic procedures. The system is intended for use with pediatric and adult patients. Learn more at Mendaera.com.  View source version on businesswire.com: https://www.businesswire.com/news/home/20250911092227/en/  Contacts  Michelle Stevens  media@mendaera.com

Mendaera Announces World's First Procedures with Focalist™ Handheld Robotic System

SAN MATEO, Calif.--(BUSINESS WIRE)--Mendaera™, Inc., a healthcare technology company developing next-generation robotics technology to simplify ultrasound-guided needle procedures, today announced the world’s first procedures performed with the Focalist™ handheld robotic system. Urologist Karen Stern, M.D., (Mayo Clinic Arizona) successfully used Focalist to achieve precise kidney access during percutaneous nephrolithotomy (PCNL), the gold standard treatment for large kidney stones. Dr. Stern p

Mendaera Announces World’s First Procedures with Focalist™ Handheld Robotic System

Cook Medical develops and manufactures minimally invasive medical devices across various medical specialties. The company offers a range of products for less invasive procedures for patients, including vascular and medsurge devices. Cook Medical serves the healthcare sector with a focus on assisting physicians in patient care. It was founded in 1963 and is based in Bloomington, Indiana.

Cook Medical

Bloomington , Ind. -- Cook Medical announced a collaboration with Mendaera , a Silicon Valley-based healthcare technology company .

Cook Medical collaborates with Mendaera™ to advance needle-based intervention with handheld robotics

EchoNous specializes in point-of-care ultrasound technology (POCUS) with a focus on artificial intelligence (AI)-enhanced devices within the healthcare sector. The company offers portable ultrasound solutions that integrate imaging capabilities and artificial intelligence to assist healthcare professionals in cardiac, lung, and abdominal assessments. It primarily serves sectors such as anesthesiology, cardiology, critical care, emergency medicine, family medicine, hospital medicine, nephrology, and vascular access. EchoNous was formerly known as Signostics. It was founded in 2016 and is based in Redmond, Washington.

EchoNous

Butterfly Network offers ultrasound devices and software solutions designed to assist in assessment, diagnosis, and treatment across various medical specialties. Its products are utilized by health systems, medical education institutions, and individual practitioners for both human and veterinary care. It was founded in 2011 and is based in Burlington, Massachusetts.

Butterfly Network

Lux Health Tech Acquisition

Johnson & Johnson

Auris Health

CareDx

EndoGastric Solutions

Invuity

Medtronic

Digital Health 50: The most promising digital health startups of 2025

Robots are coming for healthcare — here are the emerging hotspots according to recent deals

Artificial Intelligence (AI)

The digital health collection includes vendors developing software, platforms, sensor & robotic hardware, health data infrastructure, and tech-enabled services in healthcare. The list excludes pureplay pharma/biopharma, sequencing instruments, gene editing, and assistive tech.

Digital Health

Digital Health 50

Series A

Series B

Mendaera specializes in healthcare technology, focusing on robotics and artificial intelligence (AI) for medical procedures. The company develops a platform that integrates real-time imaging, robotics, and AI to support medical interventions. Mendaera's technology is intended to make healthcare services efficient and accessible. It was founded in 2020 and is based in San Mateo, California.

Mendaera

Threshold Ventures

Fred Moll

Lux Capital

PFM Health Sciences

Viz.ai provides artificial intelligence (AI) enabled care coordination solutions in the healthcare sector. Its services include analyzing medical imaging data with clear algorithms to provide insights and assessments for diagnosis and treatment decisions. Viz.ai serves healthcare providers and collaborates with life sciences partners. It was founded in 2016 and is based in San Francisco, California.

Viz.ai

Enlitic specializes in healthcare data solutions. It focuses on the integration of artificial intelligence (AI) to improve clinical workflows and data management. The company offers products that standardize and anonymize medical imaging data, contributing to the creation of a real-world evidence database for healthcare providers. It was founded in 2014 and is based in Fort Collins, Colorado.

Enlitic

Brainlab develops digital medical technology that focuses on medical tech to improve patient outcomes. The company provides solutions that digitize medical workflows from diagnosis to therapy, utilizing artificial intelligence to create three-dimensional patient-specific models that assist in surgical navigation and precision treatment. Brainlab's technologies aim to support critical surgeries and radiosurgery treatments. It was founded in 1989 and is based in Munich, Germany.

Brainlab

MVision AI specializes in the development of AI-powered tools for radiotherapy treatment planning within the healthcare sector. The company offers a comprehensive solution that automates and standardizes the contouring process in radiotherapy, aiming to improve efficiency and maintain standards. MVision AI's products are designed to reduce manual contouring time, increase consistency in treatment planning, and support continuous education for clinical teams. It was founded in 2017 and is based in Helsinki, Finland.

MVision AI

contextflow provides computer-aided detection software for chest scans. The company offers a solution that includes tools for lung cancer, interstitial lung disease (ILD), and chronic obstructive pulmonary disease (COPD) detection, such as nodule detection and tracking, lung tissue analysis, and qualitative analysis of various image patterns. It serves the healthcare sector, focusing on radiologists, picture archiving and communication system (PACS) providers, and pharmaceutical companies. contextflow was formerly known as Radiology Explorer. It was founded in 2016 and is based in Vienna, Austria.

contextflow

Aidoc offers clinical artificial intelligence (AI) solutions for analyzing medical imaging that aim to assist with workflow management, identifying key findings, and coordinating care teams. Its platform, aiOS, is designed to integrate with existing healthcare Information Technology (IT) systems and provides tools for care coordination and patient management. It was founded in 2016 and is based in New York, New York.

Aidoc

Imagen is a healthcare technology company that provides onsite diagnostic imaging solutions and interpretations, utilizing artificial intelligence for medical imaging. The company offers in-office imaging equipment, access to U.S.-based specialists, and AI software for diagnosing and documenting medical findings. Imagen primarily serves the primary care sector. It was founded in 2015 and is based in New York, New York.

Imagen

Guerbet operates in the medical imaging sector, specializing in diagnostic and interventional imaging solutions. The company offers products including contrast agents, injectors, and medical devices, as well as AI-driven solutions for medical imaging processes. Guerbet's products serve various sectors within the healthcare industry. Guerbet was formerly known as SA Laboratoires Andre Guerbet. It was founded in 1926 and is based in Villepinte, France.

Guerbet

Qure.ai specializes in leveraging artificial intelligence to enhance healthcare accessibility and affordability and focuses on the healthcare sector. The company provides artificial intelligence (AI) powered tools for medical image analysis, including chest x-ray interpretation and management of various conditions such as lung nodules, strokes, and heart failure. Its solutions are designed to assist healthcare professionals in diagnosing and treating diseases, with a significant presence in the global healthcare artificial intelligence (AI) market. It was founded in 2016 and is based in Mumbai, India.

Qure.ai

Cerebriu specializes in artificial intelligence (AI) powered radiology solutions with a focus on neuroimaging and magnetic resonance imaging (MRI) workflow automation. The company offers products such as smart alerts and smart protocols, which are designed to detect critical findings during magnetic resonance imaging (MRI) scans and adapt scanning protocols, thereby improving the efficiency of radiologists and MRI technologists. It was founded in 2018 and is based in Copenhagen, Denmark.

Cerebriu

Riverain Technologies develops AI-powered medical imaging software for the healthcare sector, specifically in radiology. The company offers FDA-cleared solutions like ClearRead CT and ClearRead X-ray, which use deep learning technology for nodule detection in thoracic imaging. These solutions assist radiologists in diagnostic tasks without the need for additional hardware or procedures. It was founded in 2004 and is based in Miamisburg, Ohio.

Riverain Technologies

deepc is a company that develops radiology AI solutions within the healthcare technology sector. Its main offerings include deepcOS®, a cloud-native Radiology AI platform that integrates AI insights into clinical workflows, and a suite of tools for automating reporting processes. The company serves radiologists, healthcare management, AI partners, and medical research groups by providing AI solutions. It was founded in 2018 and is based in Munich, Germany.

deepc

Imperative Care is a medical technology company focused on developing innovations to improve care for individuals with vascular diseases. The company offers solutions aimed at addressing treatment gaps for conditions such as stroke and pulmonary embolism. Imperative Care's business segments include specialized entities such as Imperative Care Stroke and Telos Health, each contributing to an approach to vascular health. Imperative Care was formerly known as Stroke Project. It was founded in 2015 and is based in Campbell, California.

Imperative Care

Deeptek provides artificial intelligence solutions for radiology services in the healthcare sector. The company offers solutions for radiology workflow optimization, including centralized reporting, automated analysis of chest X-rays, and tools for lung health screening. Deeptek serves hospitals and imaging centers and supports public health screening programs. It was founded in 2017 and is based in Pune, India.

Deeptek

The interventional imaging software market provides solutions for medical professionals to improve the accuracy and efficiency of interventional radiology procedures using technology. These solutions utilize machine learning algorithms to analyze medical images and assist in decision-making during procedures. This technology can help to reduce diagnostic errors, improve treatment planning, and enhance patient outcomes.

Name	Work History	Title	Status
Josh DeFonzo	Lux Health Tech Acquisition, Johnson & Johnson, Auris Health, CareDx, EndoGastric Solutions, Invuity, and Medtronic	Founder, Chief Executive Officer	Current
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Name	Josh DeFonzo	Subscribe to see more
Work History	Lux Health Tech Acquisition, Johnson & Johnson, Auris Health, CareDx, EndoGastric Solutions, Invuity, and Medtronic	Subscribe to see more
Title	Founder, Chief Executive Officer	Subscribe to see more
Status	Current	Subscribe to see more

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