Obvius Robotics has reached a major milestone in its journey to transform vascular access procedures, announcing that it successfully completed the first U.S. cases using its Certa handheld robotic platform. The company confirmed that these procedures were performed as part of a premarket clinical study for the Certa access system, marking a pivotal step forward in the commercialization of its breakthrough device. The Fort Lauderdale, Florida-based company has positioned itself at the intersection of robotics, medical devices, and image-guided surgery. Designed for procedures that demand precise needle access to anatomical structures, Certa is intended to provide operators with an unprecedented level of control and accuracy. The platform already carries FDA breakthrough device designation, reflecting its potential to significantly improve outcomes in a field where complications remain common. The initial target market for Certa is vascular access procedures, a category that represents more than 100 million procedures globally each year. At the core of Certa’s innovation is its combination of ultrasound guidance with robotic needle placement. This dual capability is designed to remove the variability that often occurs when operators with differing levels of experience perform vascular access. Traditional manual methods can result in tissue deformation or needle misplacement, especially when working with soft tissue. To address this, Obvius Robotics has developed a proprietary needle vibration technology that minimizes movement and soft tissue displacement during insertion. The company believes this refinement is the key to delivering unmatched accuracy and reliability. The first clinical use of Certa in the U.S. took place at two leading medical centers: Texas Medical Center at Baylor St. Luke’s Medical Center and Northwell Health in New York. These sites were carefully chosen for their reputations in advancing interventional medicine and for their ability to provide the clinical rigor needed in early-stage trials. According to Obvius Robotics, initial feedback from the clinical teams underscored the platform’s potential to standardize and simplify what are often complex procedures. Obvius Robotics has set out a clear regulatory timeline. Once the premarket clinical study is completed, the company intends to submit Certa for full FDA review by the end of 2025. If successful, it anticipates that approval could come as early as 2026, paving the way for a broader rollout across U.S. hospitals and eventually into international markets. This timeline also positions Obvius favorably in an increasingly competitive medical robotics sector, where handheld and minimally invasive robotic systems are gaining traction as cost-efficient alternatives to larger, fixed systems. For CEO Dave Herrmann, the motivation behind Certa’s development comes from the global need to improve consistency and reduce complications in vascular access. “There are over 100 million vascular access procedures performed each year around the world,” Herrmann said. “These procedures require significant expertise and still have high complication rates. We believe Certa can solve both of these challenges, by offering expert-level precision for any operator, regardless of their experience, at the push of a button.” Herrmann’s remarks highlight two key themes driving the adoption of robotic and AI-assisted medical devices: accessibility and consistency. While skilled interventional radiologists and surgeons can often achieve excellent outcomes, the availability of such expertise is uneven across healthcare systems. In many hospitals, especially in community or rural settings, operators may not have the same experience as those in large academic centers. By reducing the reliance on operator skill, Certa promises to democratize access to precision vascular care. The introduction of handheld robotics into this space also reflects a broader trend in healthcare: the shift from large, expensive capital equipment toward portable, cost-effective devices that can be more easily adopted by a range of providers. Unlike room-sized robotic surgery platforms, handheld devices like Certa can be used in diverse clinical environments, from tertiary hospitals to outpatient clinics. This could accelerate adoption by lowering the barriers to entry and enabling hospitals to scale precision medicine more quickly. From an industry perspective, the debut of Certa in U.S. clinical cases is more than just a company milestone; it is also a signal of where robotic-assisted medical technology is headed. With billions of dollars flowing into MedTech innovation and strong demand for tools that improve both efficiency and outcomes, platforms like Certa stand at the center of a convergence between robotics, imaging, and minimally invasive surgery. If Obvius Robotics successfully navigates the regulatory process, it could secure a first-mover advantage in the handheld robotic vascular access space—an area where competitors are only beginning to emerge. The competitive landscape for handheld robotics in healthcare The introduction of Certa by Obvius Robotics comes at a moment when handheld robotics is starting to reshape the medical device industry. Historically, robotic surgery has been associated with large-scale platforms like the da Vinci Surgical System, which have demonstrated the value of robotic precision but at the cost of high acquisition prices, steep training requirements, and infrastructure demands that limit adoption. Handheld robotic systems, by contrast, are designed to deliver precision without the same level of capital investment, making them highly attractive to hospitals and outpatient centers seeking cost efficiency. Obvius Robotics is not alone in pursuing this vision, but its positioning is distinct. By focusing initially on vascular access, the company is entering a clinical area with enormous procedure volumes and persistent unmet needs. Unlike more complex surgeries that require multiple incisions and longer operating times, vascular access is performed daily in virtually every hospital worldwide. This creates a scalable entry point for Certa, enabling widespread adoption without the long procurement cycles often associated with robotics. Competitors in this space include early-stage MedTech startups exploring handheld systems for orthopedic procedures, biopsies, and neurosurgery. Yet few have targeted vascular access with the same intensity. This gives Obvius Robotics a first-mover advantage in a high-volume specialty where efficiency gains can translate quickly into cost savings for healthcare systems. Furthermore, the FDA breakthrough device designation strengthens its regulatory credibility, signaling that the agency sees potential for significant improvement in patient outcomes. Market adoption drivers For healthcare providers, the appeal of handheld robotics lies in several converging factors: 1. Clinical precision: By integrating ultrasound guidance and robotic control, Certa can reduce the risk of complications such as misplacement, hematoma, or infection, which remain common in manual vascular access procedures. 2. Operational consistency: Hospitals face constant pressure to standardize care. Certa promises to deliver expert-level accuracy independent of operator experience, ensuring uniform outcomes. 3. Economic impact: Complications from vascular access not only harm patients but also drive up costs through extended hospital stays or repeat procedures. A device that minimizes these risks aligns with hospitals’ value-based care objectives. 4. Scalability: Unlike large robotics platforms, handheld devices can be deployed flexibly across departments, expanding their utility beyond a single surgical specialty. Obvius Robotics’ choice to begin clinical testing at institutions like Baylor St. Luke’s Medical Center and Northwell Health is also strategic. These hospitals are not only leaders in adopting new technology but also serve as reference centers that can influence broader adoption across regional and national networks. Broader MedTech context The rise of handheld robotic systems is part of a larger movement toward miniaturization, portability, and AI integration in medical devices. Where previous generations of robotic technology emphasized scale and automation, the new wave is focused on accessibility and adaptability. AI-enabled image guidance, real-time feedback, and intuitive user interfaces are making robotics less intimidating for clinicians and lowering training barriers. This shift aligns with a healthcare ecosystem that increasingly prioritizes outpatient care and decentralized service delivery. As more procedures move away from large hospital operating rooms into ambulatory surgical centers (ASCs) and even office-based practices, compact and cost-efficient robotic systems are poised to meet the demand. Devices like Certa fit this model perfectly, promising to bring robotic precision to high-volume procedures without the overhead of traditional systems. Investment and industry momentum The MedTech investment landscape underscores the potential of this segment. Venture capital funding into surgical robotics and AI-guided medical systems has surged in recent years, reflecting investor confidence in technologies that promise both clinical and economic benefits. While most of the capital has flowed into established robotic surgery platforms, handheld devices are now attracting attention for their ability to penetrate markets more quickly and at lower cost. If Obvius Robotics can demonstrate strong clinical outcomes in its current trials, it will be well-positioned to capture early adoption among hospitals and ASCs seeking innovation without heavy infrastructure investments. Success here could also attract strategic partnerships with larger MedTech players looking to expand their portfolios into handheld systems, or even trigger acquisition interest from industry giants. The trajectory for handheld robotics may mirror other disruptive MedTech innovations, where compact, portable solutions ultimately expanded the market far beyond its initial boundaries. Just as portable ultrasound transformed imaging by moving it out of radiology departments and into emergency rooms and clinics, handheld robotics could democratize access to robotic precision across a wide range of medical disciplines.
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