Taiwanese medical device manufacturer Point Robotics has developed the Kinguide Agile Hybrid Navigation System, which significantly reduces operation time and intraoperative radiation exposure. With over 500 successful clinical cases completed, the company now aims to build a comprehensive robotic platform for spinal surgery.
Spinal surgery is widely regarded as high-risk and technically challenging due to its proximity to critical nerves and major blood vessels. Whether performed via traditional open surgery or the more modern minimally invasive techniques, the outcome depends heavily on the surgeon’s experience and tactile judgment. In minimally invasive spine surgery, small incisions and the complex structure of the spine make visualization difficult and accurate positioning even more so, requiring numerous intraoperative X-rays—thereby increasing radiation exposure for both patients and medical staff.
Since its founding in 2016, Taiwan-based medical device company Point Robotics has focused on developing navigation and robotic systems for spinal surgery. Its flagship innovations—the Kinguide Agile Hybrid Navigation System and the Kinguide Robotic Assisted Surgical System—address these pain points. These systems provide preoperative and intraoperative planning with high precision, significantly reducing the need for X-rays and cutting radiation exposure for both patients and medical staff to about one-third of the traditional level. Both technologies received certification from the U.S. FDA and Taiwan’s TFDA in 2022 and 2023, respectively. Global partnerships, including with India and North America, are also in progress.
According to Point Robotics CEO SC Juang, surgical navigation can significantly reduce the risks associated with spinal procedures by enabling more precise planning and execution. The company has recently integrated robotic arms to assist with pedicle screw placement during surgery. The Kinguide Agile Robotic Arm Surgical Stereotactic System received Taiwan TFDA approval in June 2025. This new device supports efficient one-stop screw insertion and decompression procedures, advancing Point Robotics’ goal to establish a fully integrated robotic spine surgery platform.
As Taiwan’s first domestic manufacturer specializing in spinal navigation and robotics, Point Robotics complies not only with local regulations but also international quality standards. Milestones include:
- 2016: Licensed as a medical device manufacturer in Taiwan
- 2021: Xindian plant certified for Quality Management System (QMS)
- 2023: Certified for EN ISO 13485:2016 medical device QMS
- 2023: Certified under the Foreign Manufacturer Quality System Documentation (QSD) program
The company obtained FDA approval via the 510(k) pathway, demonstrating substantial equivalence with three leading international technologies. Juang noted that despite internal challenges during alignment and fine-tuning, the team secured certification within six months. Going forward, the company aims to actively pursue patents and certifications for its new technologies.
“Certification doesn’t guarantee success. Surgeons must find the system truly helpful and be willing to use it,” said Juang. Point Robotics takes a user-centered design approach: the system adapts to surgeons, not the other way around. From early development stages, the company engaged directly with surgeons in operating rooms to refine workflows and improve usability.
To date, Point Robotics has collaborated with over 30 hospitals and 50 surgeons, completing more than 500 clinical surgeries with excellent patient recovery outcomes. For each surgery, the company deployed engineers to assist in real time—gathering feedback to continuously improve the system’s design.
With the aim of covering over 90% of spinal surgical procedures, Juang has set a target of reaching 1,000 successful clinical cases within a year. This will help enhance system performance, broaden its procedural compatibility, and incorporate diverse clinical perspectives—boosting the platform’s maturity and scalability.
Compared to global medical giants such as Medtronic and Johnson & Johnson, Juang believes Point Robotics offers unique advantages: flexibility, modularity, and a comprehensive solution strategy.
Generally, spine surgeries are typically categorized into “additive” (e.g., screw insertion, cement injection) and “subtractive” (e.g., bone or disc removal) procedures. In the additive realm, the company is developing a One-Step Screw Insertion function that integrates custom-designed screws and optimized tools to streamline the entire screw placement process.
For subtractive surgeries—which are generally more time-consuming—Point Robotics has created a Decompression Bone Removal robot. This device achieves millimeter-level bone grinding, even thinner than an eggshell, with high precision to avoid damaging nearby nerves or tissues.
Juang envisions the system’s core spine navigation module being flexibly paired with optional modules for endoscopy, screw insertion, and decompression. The ultimate goal is to establish a comprehensive spinal surgical robotic platform, supporting next-generation smart operating rooms. By leveraging homegrown technology and agile modular integration, Point Robotics is paving the way for Taiwan’s medical device sector to compete on the global stage.
- Company Name: Point Robotics
- Specialty: Development of robotic-assisted systems for minimally invasive spinal surgery, offering solutions that prioritize precision, safety, minimal invasiveness, and low radiation exposure
- Certifications:
• Kinguide Agile Robotic Arm Surgical Stereotactic System: TFDA (2025)
• Kinguide Agile Hybrid Navigation System: TFDA (2022), FDA (2023)
• Kinguide Robotic Assisted Surgical System: TFDA (2022), FDA (2022)
