InnovationHealthcareHealthcare Robotics Pioneer Mendaera Announces FDA anceByDr. Sai Balasubramanian, M. , Contributor. Forbes contributors publish independent expert analyses and insights.
Sai writes healthcare, innovation and nology. AuthorJul 08, 2025, 08:30am EDTImage-guided needle cedures are one of the most foundational aspects of modern healthcare.
Getty Healthcare robotics pioneer Mendaera announced today that it has received U.
Food and Drug Administration (FDA) 510(k) ance for its handheld robotic system, Focalist, which aims to enhance ultrasound guided needle placement across a variety of medical and healthcare specialties.
Specifically, the system integrates the use of a handheld module, real-time ultrasound imaging and prietary software to simplify needle positioning, depth-tracking and placement to enable simplicity, consistency and reducibility in needle based cedures.
Why is this important. Image-guided needle placement is one of the most fundamental cedures across numerous specialties, including for accessing vital organs (e.
, for biopsies), establishing vascular access (e. , central or arterial lines) and for managing pain and anesthesia (e. , sedation for cedures).
Furthermore, these cedures often require an incredible amount of patience, coordination, spatial perception and training to execute correctly, introducing a wide spectrum in the quality of care vided.
The point of nologies such as Focalist is to introduce consistency and standardization in care experiences. In fact, nearly 9 million biopsy cedures were conducted in 2022 alone.
A study published in The Journal of the Missouri State Medical Association found that “Using modern tools to incorporate cedural skills training and ultrasound simulation” can vastly imve “clinical practice and decision-making by increasing confidence and competence with ultrasound needle-guided cedures.
” Furthermore, it describes the importance of mastering competency in cedural elements, such as needle placement, as a critical aspect of modern medicine; precision with these niques is ultimately paramount to reducing the risk of misplacement and complications.
Another study, published in Photoacoustics, describes how “Accurate needle guidance is crucial for safe and effective clinical diagnosis and treatment cedures” and also explains that needle insertion cedures are frequently victim to “challenges in consistency and precise visualization of the needle.
” Indeed, optimizing for time efficiency, precision and consistent experiences across the millions of cedures done annually at health systems introduces a massive burden on a healthcare workforce that is already stretched thin.
This is where nology such as Mendaera’s can truly add value—as a means to enable consistency and perhaps alleviate workflow burdens by making each cedure more lined.
The company is initially focusing on applications in urology, a speciality that is known for a high frequency of these cedures.
Fuchs, fessor of Clinical Urology at the University of Southern California, explains that “Simplifying ultrasound-guided percutaneous access is one of the most impactful ways to imve efficiency, safety, and independence in urology and beyond…Mendaera’s platform represents a meaningful evolution - one with the potential to broaden access to minimally invasive cedures and elevate the standard of care.
” MORE FOR YOU Below is a 30 second demo of how Mendaera’s platform works: Of course, there is a significant amount of work being done and competition in this field by a variety of different players.
For example, in academic settings, scientists are trying to leverage deep learning and artificial intelligence to enhance needle visibility and imve image and anatomy detection.
Other academics recognize the lack of data available to train AI models to assist in needle and target detection, and hence are working on understanding how synthetic data can instead be leveraged to train these systems.
With regards to specifically the needle-based intervention space, XACT Robotics was granted FDA ance in 2022, but eventually shutdown due to a variety of market challenges.
Another minent player is Interventional Systems, which received 510(k) FDA ance in 2023 for its percutaneous CT system, and has since continued to expand its presence in the market.
Peter Hebert, partner and co-founder of Lux Capital, which is a key investor in Mendaera, explains that “AI, real-time imaging, and innovative hardware can help bring the substantial benefits of medical robotics to main cedures.
" He also addresses a central pain point: “As healthcare faces growing labor shortages and cost constraints, nology can be employed to enhance patient experiences while imving the efficiency of health systems.
Mendaera’s Focalist system is uniquely positioned to der the benefits of robotics – namely precision, consistent quality and efficiency – more broadly across healthcare.
” Despite a challenging landscape, the competition has forced rapid innovation.
Nevertheless, there need not be only one winner; instead, the space is certainly wide enough for multiple players to work towards imving both workforce burdens and consistency in the patient experience.
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