Fort Lauderdale, FL – September 4, 2025 – The first U.S. clinical cases using the CERTA™ Access System, a handheld robotic platform for precision vascular access, have been successfully completed. The system, combining ultrasound guidance, robotic needle placement, and proprietary vibration technology, aims to set a new benchmark in minimally invasive procedures.
Science Significance
Vascular access procedures, numbering over 100 million annually worldwide, often rely heavily on operator skill and carry a risk of complications. The CERTA Access System addresses these challenges by automating precise needle placement. Its vibration-assisted robotic mechanism reduces soft tissue deformation during insertion, offering enhanced accuracy in reaching targeted anatomical structures. This innovation signals a paradigm shift in clinical science, where automation and robotics support safer, more consistent outcomes.
Regulatory Significance
The U.S. FDA has granted Breakthrough Device Designation to the CERTA Access System, recognizing its potential to improve patient outcomes in high-risk, high-volume procedures. Completion of ongoing clinical studies is expected to pave the way for a submission to the FDA by late 2025, with possible approval in 2026. This designation accelerates regulatory review pathways for technologies addressing unmet medical needs.
Business Significance
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The vascular access market represents a large and high-demand clinical space. With over 100 million procedures annually, the adoption of robotic-assisted devices could transform care delivery while lowering the burden on highly skilled operators. By democratizing access to expert-level precision, the CERTA platform positions itself as a scalable MedTech innovation with strong commercial potential in both advanced and resource-limited healthcare systems.
Patients’ Significance
For patients, this advancement promises safer, quicker, and more reliable vascular access procedures. Reduced complication rates, combined with the ability to deliver consistent outcomes even with less experienced operators, means patients could benefit from greater accessibility to high-quality care, regardless of geography or clinical setting.
Policy Significance
The breakthrough aligns with global healthcare policy goals focused on improving patient safety, reducing procedure-related complications, and addressing skill shortages in critical care. Robotic and image-guided innovations like CERTA support the push toward standardization of care and could influence future guidelines for vascular and critical access procedures.
The CERTA Access System represents more than a technological leap; it signifies a new era where robotics and clinical practice merge to create a potential standard of care in vascular access. With regulatory pathways accelerating and early clinical success established, the coming years may see this innovation redefine how precision access procedures are performed worldwide.
Source: OBVIUS Robotics, Inc. Press Release
