On October 26, Edge Medical®'s independently developed Edge Cloud® telesurgery system officially obtained EU CE certification (under the MDR), clearing it for robotic telesurgery in urology, general surgery, thoracic surgery and gynecology. It can be used in combination with the Edge Medical® multi-port laparoscopic surgical robot, single-port laparoscopic surgical robot, and the single-/multi-port surgical robot super system. With this, Edge Medical® becomes the first company worldwide to obtain EU CE certification across its full range — the multi-port, single-port and integrated multi-/single-port super system, and the telesurgery system.

From the multi-port and single-port systems to the integrated multi-/single-port super system, and on to the telesurgery system, Edge Medical® has moved from certifying a single product to a full-platform footprint in Europe — assembling a complete product matrix that covers multiple surgical approaches and remote-collaboration scenarios. This is not only a key milestone in Edge Medical®'s globalization, but also a signal that China-born surgical-robot companies, through platformized products, cross-border clinical practice and systematic telesurgery capability, are now deeply engaged in building the next phase of global robotic surgery.

In recent years — from Rome to Beijing, from Barcelona to the Canary Islands; from the first-in-human clinical explorations to a global-first multicenter randomized controlled trial of telesurgery published in The BMJ; from completing a single cross-region operation to building remote-control centers, training centers and cross-border collaboration networks — Edge Cloud® is moving telesurgery from “bridging distance” to “replicating capability”, shifting from “technically feasible” toward “clinically credible, system-ready and globally accessible”.

A Global First

A European Market-Access Map Covering Multi-Port, Single-Port, the Integrated Multi-/Single-Port Super System and Telesurgery

Europe is among the world's most demanding and clinically mature markets for medical-device regulation. The EU Medical Device Regulation (MDR) sets systemic requirements for the safety, performance, clinical evaluation, risk management and full-lifecycle quality systems of medical devices. For a telesurgery system, the conformity assessment covers far more than the robot itself — it spans cross-region master control, 3D image transmission, network adaptation, data security and risk redundancy, and more.

Edge Medical®'s entry into Europe has never been a single breakthrough but a steadily advancing product-matrix path. In March 2025, the Edge® multi-port laparoscopic surgical robot system obtained EU CE certification; in October the same year, the Edge® single-port laparoscopic surgical robot and the single-/multi-port surgical robot super system received EU CE certification. Now, as the Edge Cloud® telesurgery system is certified, Edge Medical®'s European product map extends from on-site robotic surgery to cross-region surgical collaboration, achieving comprehensive coverage across the multi-port, single-port, integrated multi-/single-port super system and telesurgery systems.

This certification is also a watershed for Edge Cloud® in Europe — moving beyond cross-border demonstrations and project validation toward broader clinical collaboration, remote training and regional-network buildout. The multi-port platform broadly covers complex laparoscopic procedures; the single-port platform targets precise operations through ever-smaller incisions; the integrated multi-/single-port super system improves adaptability across surgical approaches; and the Edge Cloud® telesurgery system breaks through the physical boundaries of the operating room. Working in concert, the four form an overall solution spanning different departments, procedures, institutions and regional-collaboration needs.

Behind the CE Certification

Telesurgery is accelerating from technical breakthrough to the clinic

The most tangible sign of telesurgery is that a surgeon and a patient thousands of kilometers — even intercontinental — apart can still share the same operative rhythm. But what truly determines whether it can enter routine clinical practice is not the distance on a map; it is whether, under complex network conditions, the system can consistently deliver stability, clarity, control and traceability.

Around the core risks of telesurgery, Edge Cloud® has built a technical system spanning communication, imaging, control and safety assurance: dynamic ROI video coding keeps critical surgical fields sharp while lowering transmission load; support for 5G, dedicated lines, broadband and other network access, with multi-network fusion and backup mechanisms, strengthens link resilience; proprietary transport protocols and encryption safeguard data and control-command integrity; and dual-control-console coordination and near-end takeover and other mechanisms establish safety redundancy for cross-region operation.

More importantly, this system has long since moved beyond the laboratory and single demonstrations. To date, Edge Cloud® has supported nearly 1,000 telesurgery explorations worldwide. Across different distances, network conditions, disciplines and countries, these sustained practices are moving telesurgery from “technically achievable” toward “clinically verifiable, system-operable and regionally replicable”.

From a Single Breakthrough to Multi-Site Collaboration

A Global Telesurgery Network Takes Shape at Speed

Before this CE certification landed, Edge Cloud® was already continuously entering real clinical settings and international academic scenarios in multiple countries — some validating the routine operation of cross-region collaboration, some undertaking high-difficulty complex procedures, some exploring multi-disciplinary sequential collaboration, and some scaling a single project up into national healthcare-system buildout.

In May 2026, the International Hepato-Pancreato-Biliary Association (IHPBA) China Congress staged the first “Robotic Telesurgery Live-Streaming Week.” In a single week, the Edge® robot supported 13 telesurgery live-streams, linking sites across Wuhan, Jingzhou, Beijing, Hefei and Shanghai, and connecting internationally to Uzbekistan, Georgia and Greece — covering gastrointestinal, hepatobiliary, urologic and thoracic procedures and earning praise from experts at home and abroad. Telesurgery is extending from a single connection line into a network spanning multiple cities, countries and disciplines.

In August, propelled by the relevant bodies of the Saudi Ministry of Health, King Saud University Medical City and institutions including the Seha Virtual Hospital jointly launched a national-level robotic telesurgery program, with the Edge® robot and its telesurgery system serving as the core technology platform. The significance of the program lies not only in completing operations but in exploring an extensible, national-level model for telesurgery.

In September, at the UAA Congress 2026 held in Manila, Philippines, the Edge® robot completed a cross-border telesurgery live-stream of roughly 3,000 kilometers from Manila to Beijing; in the same period, at APAGE 2026 in Jakarta, Indonesia, a telesurgery operation — from Wuhan to a complex-case gynecology center — was delivered to an expert in Singapore. By now, Edge Cloud®'s applications have expanded from urology into gynecology, general surgery and thoracic surgery, and the collaboration network has extended from multiple domestic sites across China to broader regions including Europe, Asia and the Middle East.

From “Being Able To” to “Being Able To Prove It”

Edge Cloud® Advances Telesurgery into Evidence-Based Medicine

For a high-risk, innovative technology to enter routine clinical use, landmark cases are needed — as are repeatable clinical outcomes, standardized collaboration workflows and high-level evidence. Around telesurgery, Edge Medical® and its clinical experts have kept advancing clinical validation along the path of animal experiments, exploratory first-in-human clinical work, multicenter studies and randomized controlled trials.

In 2023, the urologic telesurgery study jointly conducted by Academician Zhang Xu's team at the Chinese PLA General Hospital and Edge Medical® was published in European Urology, reporting clinical explorations across distances of some 3,000 kilometers and multiple procedure types. In 2025, led by Academician Chen Xiaoping's team at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, and in partnership with Edge Medical®, the world's first prospective clinical study of a robotic liver resection telesurgery system was published in eClinicalMedicine, a Lancet Discovery Science journal, extending remote evidence-based practice to highly complex hepatobiliary and pancreatic surgery.

In 2026, a multicenter, single-blind, non-inferiority randomized controlled trial — led by the Chinese PLA General Hospital with five hospitals participating — was published in The BMJ. The study enrolled 72 patients at telesurgery distances of 1,000 to 2,800 kilometers, providing higher-level evidence for comparing robotic telesurgery with on-site robotic surgery.

From “completing one operation” to “building a body of evidence”, Edge Cloud® is answering, through sustained clinical research, the key questions on the path of telesurgery toward routine use.

From a Single System

Toward Global Surgical-Collaboration Infrastructure

At the same time, Edge Medical® keeps advancing the buildout of remote-control centers, training centers and regional collaboration networks. The dual console provides not only a safety safeguard but also the technical basis for remote mentoring, expert guidance and cross-site collaboration. The long-term value of telesurgery is shifting from “an expert crossing distance to complete one operation” to “continuously delivering standards, experience and talent-development mechanisms to more hospitals.” As the multi-port, single-port and telesurgery systems together complete European market access, what Edge Medical® offers the global market is no longer a single device but a platformized capability that adapts to different surgical approaches, procedures and collaboration ranges.

In the future, Edge Medical® will continue to work hand in hand with clinical experts and healthcare institutions worldwide, exploring further around the safety, stability, clinical standards, evidence-based research and scaled application of telesurgery, and driving Edge Cloud® to grow further into an intelligent surgical infrastructure that connects doctors, hospitals and patients. Let distance no longer set the boundary of surgical capability, and let quality surgery and teaching resources cross mountains and seas to arrive safely and reliably.

This is both the direction in which Edge Cloud® keeps moving forward, and the future telesurgery is truly worth looking forward to.