Suzhou SightMed Receives FDA Clearance for ArtiNimble™ Multi-Degree-of-Freedom Handheld Robotic Arm, Paving the Way for Commercialization

Recently, Suzhou Shitong Medical Technology Co., Ltd. (hereinafter referred to as “Shitong Medical”) successfully obtained U.S. FDA market clearance for its multi-degree-of-freedom handheld robotic arm, ArtiNimble™. This achievement not only signifies recognition from the world’s most authoritative regulatory body but also marks another major milestone for Shitong Medical in the field of natural orifice flexible surgical robots.

As the concept of minimally invasive surgery becomes increasingly widespread, more and more traditional open surgeries are being replaced by minimally invasive procedures. Surgeries that once required thoracotomy are now increasingly performed using laparoscopic minimally invasive techniques. However, the penetration rate of minimally invasive surgery in China is only 40%, representing a significant gap compared to the nearly 90% penetration rate observed overseas during the same period. Even in some top-tier tertiary hospitals in China, this figure remains unsatisfactory. If extended to third- and fourth-tier cities across China, the penetration rate is likely even lower. One important reason for this is that in highly difficult, complex, and delicate laparoscopic minimally invasive surgeries—particularly when the surgical field is located near vital organs or tissues—traditional suturing and resection maneuvers become exceptionally challenging. In some cases, the angle of the trocar access path is parallel to the surgical field, resulting in limited operating space and hindering surgeons’ maneuverability, thereby restricting the further increase in the penetration rate of minimally invasive surgery.

In recent years, high-end medical devices represented by the da Vinci Surgical System have successfully addressed this challenge by leveraging the multi-degree-of-freedom articulation of their end-effectors. When tackling previously intractable and complex surgeries, these systems enable rapid resection or suturing of lesions, significantly improving surgical success rates. However, the widespread adoption of surgical robots has been constrained by prohibitive equipment costs and regulatory restrictions on the allocation of licenses for large-scale medical devices. Consequently, only physicians at top-tier tertiary hospitals have the opportunity to utilize these systems in clinical practice, while the vast majority of doctors in third- and fourth-tier cities across China can typically only “experience” surgical robots and appreciate the advantages of multi-degree-of-freedom articulated instruments on rare occasions, such as at trade exhibitions.

Adhering to its consistent philosophy of developing “flexible, miniaturized, and low-cost” surgical robots, Shitong Medical has creatively applied robotic surgery to general surgery, thoracic surgery, and other fields by leveraging its existing product technology platform to address the aforementioned clinical pain points constrained by various factors. The company has successfully designed a “multi-degree-of-freedom handheld robotic arm.” This device is suitable not only for traditional procedures such as hernia repair and intestinal anastomosis but also for extremely complex and precise minimally invasive surgical scenarios.

Unlike traditional straight-shaft laparoscopic surgical instruments, which require complex knobs or buttons for articulation, Shitong Medical’s multi-degree-of-freedom handheld robotic arm can simulate the surgeon’s hand movements in real time with zero latency. This enables the instrument tip to follow the surgeon’s hand with 360° infinite rotation, significantly expanding the reachable area for clinical procedures, ensuring precision in position and orientation, and reducing the clinical learning curve for complex and delicate surgeries. Meanwhile, authentic haptic force feedback technology allows surgeons to intuitively perceive tissue resistance, facilitating more precise surgical manipulation. Furthermore, the platform-based application of flexible instrument technology and modular manufacturing processes have substantially reduced production costs, greatly enhancing the product’s market competitiveness.

Shitong Medical was established in August 2022. Leveraging platform-based technologies, the company develops flexible, miniaturized, and cost-effective surgical robots, striving to become a technological pioneer and market leader in the field of natural orifice flexible surgical robotics globally. Its R&D product portfolio covers multiple clinical specialties, including gynecology, gastroenterology, neurosurgery, and general surgery. Currently, several overseas companies have obtained regulatory approvals and commenced commercial promotion in the field of natural orifice surgical robotics. Shitong Medical will continue to deepen its R&D efforts in natural orifice surgical robots, overcoming professional barriers in flexible robotics through original technologies, and promoting the industrialization of natural orifice surgical robots in China.

The company has secured multiple rounds of financing and support from top-tier institutions such as Proxima Ventures and Yuanhe Holdings. Currently, the Pre-A+ round of financing is progressing steadily, with preparations underway for clinical trials following the finalization of the surgical robot system’s design, as well as for subsequent commercialization efforts. We are confident that more patients will benefit from Shitong Medical’s intelligent and precise surgical robotic treatment solutions in the future.

We are fully aware that only through broader dissemination and application can a good product truly realize its commercial value. Here, we sincerely welcome agents, distributors, and industry partners to contact us (click the link on the righthttps://www.wjx.cn/vm/wFtR2Ll.aspx, fill in the relevant information).

Let us join hands to benefit a broader community of physicians and patients!