On March 19, 2026, the Edge® Single-Port Robot (SP1000) received approval from the National Medical Products Administration (NMPA) for a change to its medical device registration (Registration Certificate No.: 20233011753), with the intended use updated to: “This product is operated by physicians through a master-slave control system to manipulate minimally invasive surgical instruments, and is intended for endoscopic surgical procedures in gynecology, urology, general surgery, and thoracic surgery.”

With this registration change approved, the applicable scope of the Edge® Single-Port Robot (SP1000) has been further expanded to thoracic surgery, achieving coverage across the four major surgical disciplines: gynecology, urology, general surgery, and thoracic surgery. Based on currently available public information, this is the first domestic single-port surgical robot to include all four core departments within its indicated use.

Whether a single-port system can expand into more surgical specialties depends on two key factors: first, whether instruments can be stably deployed and retracted within a single incision; and second, whether operational feel and precision can remain consistent across different anatomical spaces. Gynecology and urology are relatively “structured,” general surgery becomes more complex, while thoracic surgery presents even tighter spaces, more pronounced bony obstructions, and greater limitations on instrument articulation and multi-instrument coordination. The ability to cover this specialty indicates that the system has withstood validation in more complex scenarios in terms of control, structural design, and clinical adaptability.

From MedRobot’s perspective, the Edge single-port product line has now been largely established. After covering the four core departments, the system’s usage boundaries within hospitals will expand significantly, and it will also be easier to integrate with multi-port platforms and remote systems.

Within the broader progress of domestic surgical robots, such advancement in both speed and completeness is already difficult to ignore. 

The following is the official release from Edge Medical, provided for readers’ reference:

From Gynecology to Full Coverage of Four Major Departments

Clinical Expansion Capability of Edge Single-Port Technology Validated

For a long time, single-port surgical robots have been regarded as a high-barrier segment within the field of surgical robotics due to their high technical complexity, difficulty in system integration, and high threshold for clinical validation. Edge Medical® has continuously advanced its single-port products starting from gynecology, gradually expanding into urology and general surgery, and now reaching thoracic surgery with this approval, steadily progressing along the path of “product registration – clinical implementation – specialty expansion – ecosystem development.”

Prior to this registration change, the Edge® Single-Port Robot (SP1000) had already accumulated a large number of successful clinical cases in gynecology, urology, and general surgery, with total clinical procedures exceeding 2,000 cases, and in collaboration with clinical experts, successfully completed multiple “world-first” innovative procedures. These include the world’s first single-arm single-port robotic remote surgery, the world’s first same-day discharge radical colectomy using a single-port robot, and the world’s first simultaneous minimally invasive surgery combining low rectal cancer radical resection with sphincter preservation (NOSES-I approach) and liver metastasis resection. At the same time, Edge Medical® also promoted the publication of China’s first Expert Consensus on Robot-Assisted Radical Prostatectomy Using Domestic Single-Port Systems, laying a solid foundation for the standardized development of the discipline.

Compared with traditional multi-port approaches, single-port surgery enters the body through fewer incisions, offering inherent advantages in reducing trauma, optimizing postoperative recovery, and improving cosmetic outcomes. Thoracic surgery is one of the specialties that demands extremely high precision in confined spaces. With 540-degree articulating instruments, sub-millimeter precision, and high-definition three-dimensional visualization, the Edge® Single-Port Robot (SP1000) enables efficient multi-instrument coordination through a single incision, effectively overcoming challenges posed by rib cage obstruction. The expansion of its indication to thoracic surgery not only signifies regulatory recognition of its capability in complex anatomical environments, but also further validates the clinical scalability of Edge Medical®’s single-port technology pathway.

Platform-Based Layout Advances Further

Edge Medical Accelerates Toward a System-Level Solution Provider

As the first company in China and the second globally to obtain regulatory approval for multi-port robotic surgical systems, single-port robotic surgical systems, and natural orifice surgical robots, Edge Medical® has established a diversified product portfolio covering different treatment scenarios. Earlier this month, Edge Medical’s fully self-developed “multi-port + single-port + remote” integrated surgical robotic platform was approved by the NMPA for market launch. This “three-in-one” platform is currently the only system that deeply integrates multi-port, single-port, and remote capabilities into a single platform.

The approval of this registration change for the single-port robot marks another important step for Edge Medical® in continuously improving its platform-based layout and strengthening multi-scenario surgical coverage. As its multi-port, single-port, natural orifice, and remote surgical systems continue to integrate, Edge Medical® is moving from single-product breakthroughs toward becoming a systematic provider of minimally invasive surgical solutions. In the future, the company will continue to deepen collaboration with hospitals both domestically and internationally through “clinician-engineer integration”, leveraging its diversified product portfolio—including multi-port, single-port, natural orifice, and remote surgical systems—to enable more patients worldwide to benefit from precise, safe, and comfortable minimally invasive surgical services driven by “Made in China” innovation.

March 25, 2026