The Israeli-based company is moving closer to making robotic cataract and eye disease surgery a reality.
ForSight Robotics (Yokne’am Illit, Israel), a company specializing in ophthalmic robotic surgery, has announced its achievement of ISO 13485:2016 certification, a globally recognized standard for quality management systems in the medical device industry.1
Dr. Joseph Nathan, co-founder, president and chief medical officer of ForSight Robotics, emphasized the significance of this certification: “This milestone not only reinforces confidence in the ORYOM Platform but also validates the rigorous processes we have in place as we advance toward patient trials and future regulatory approvals.”
ORYOM: A closer look at the robotic platform
ForSight Robotics is developing the ORYOM Platform, which the company describes as the world’s first robotic surgical system designed for cataracts and other eye diseases. The system integrates AI-driven algorithms, computer vision and micromechanics to enhance precision in eye surgery.2
The ORYOM Platform features a 14-degree freedom microsurgical robot capable of performing highly delicate tasks. Its hybrid kinematic structure allows surgeons to access any point within the eye, potentially increasing flexibility for complex procedures.
Additionally, the platform includes stereoscopic imaging technologies for real-time visualization and surgical planning, aiming to enhance accuracy and control during operations. The system also utilizes machine learning to refine surgical techniques continuously, with the goal of optimizing procedural efficiency and patient outcomes.
ORYOM Platform debut at ASCRS 2024
The ORYOM Platform was first showcased at the 2024 ASCRS Annual Meeting, where Dr. David F. Chang, a renowned cataract surgeon and past ASCRS President, presented the first-of-its-kind robotic cataract procedure on a porcine eye.3
During his Charles D. Kelman Innovator Lecture, Dr. Chang shared his experience using ForSight Robotics’ ORYOM Surgical Robotics Platform to complete a full, remote robotic cataract procedure.
ForSight Robotics states that this certification strengthens its ability to meet stringent regulatory requirements, positioning the company for future approvals and market expansion. As the company scales, it remains focused on continuous improvement, aiming to maintain high levels of quality, safety and innovation in ophthalmic robotic surgery.
References
- Business Wire. ForSight Robotics Achieves ISO 13485:2016 Certification. Available at: https://www.businesswire.com/news/home/20250226803615/en/ForSight-Robotics-Achieves-ISO-134852016-Certification Accessed on February 28, 2025.
- The ORYOM Platfrom. ForSight Robotics. Available at https://www.forsightrobotics.com/oryom/#section-platform Accessed on February 28, 2025.
- Surgical Robotics Technology. ForSight Robotics Completes Robotic Cataract Surgery Using ORYOM Platform, April 2024. Available at https://www.surgicalroboticstechnology.com/news/forsight-robotics-completes-robotic-cataract-surgery-using-oryomtm-platform/ Accessed on February 28, 2025.
