AGIBOT Endoscopic Surgical Robot

Developed by Agile Medical Technology, the AGIBOT Endoscopic Surgical Robot is a four-arm platform designed for minimally invasive procedures across thoracic, abdominal, and pelvic cavities. The system received NMPA clearance in March 2025, with clinical validation spanning over 130 procedures across six surgical specialties.

Product Overview

The AGIBOT system represents Agile Medical Technology’s flagship surgical robot, targeting multi-specialty applications in minimally invasive surgery. Designed as a multi-specialty platform, the system integrates a surgeon console, four-arm patient cart, vision processing unit, and a suite of 11 instrument types.

The platform emphasizes clinical accessibility with features including deployment guidance, third-party imaging integration, and a training program for surgeon onboarding. Initial NMPA approval covers urological surgery indications, with additional specialty approvals in development.

Key Features

AGIBOT is a four-arm endoscopic surgical robot by Agile Medical Technology, receiving NMPA clearance in March 2025 after completing over 130 procedures across six surgical specialties.

• Immersive 3D Visualization: Ultra-HD stereoscopic display at the surgeon console providing depth perception for precise tissue manipulation
• Lightweight Master Control Arm: Multi-degree-of-freedom design optimized for ergonomic operation and reduced surgeon fatigue
• Dual-Motor Tiller Mechanism: Enables single-handed instrument positioning with flexible deployment configurations
• Four-Arm Patient Cart: Deployment guidance functionality assists with optimal arm positioning and workspace management
• Multi-Source Image Integration: Compatible with HD 3D laparoscopes, 4K 3D fluorescence laparoscopes, and external imaging (ultrasound, CT, endoscopy)
• Reusable Instruments: 11 instrument types designed for multi-procedure utilization

Technical Specifications

AGIBOT is a four-arm endoscopic surgical robot by Agile Medical Technology, integrating 11 reusable instrument types with HD 3D and 4K fluorescence laparoscope compatibility under TÜV SÜD ISO 13485 quality certification.

Clinical Applications

The AGIBOT system has demonstrated clinical applicability across multiple surgical departments:

Urological Surgery (NMPA Approved)

• Radical prostatectomy
• Partial nephrectomy
• Pyeloplasty

Hepatobiliary Surgery

• Hepatectomy
• Cholecystectomy

Gastrointestinal Surgery

• Gastrectomy
• Colectomy

Colorectal Surgery

• Low anterior resection
• Abdominoperineal resection

Gynecological Surgery

• Hysterectomy
• Myomectomy

Thoracic Surgery

• Lobectomy
• Thymectomy

During registration clinical trials (December 2023 - December 2024), the system completed over 130 procedures across these specialties at multiple centers including Nanjing Drum Tower Hospital, PLA General Hospital, and First Affiliated Hospital of Zhengzhou University.

Regulatory Status

Initial NMPA approval covers urological surgery indications. The company has stated plans to pursue additional specialty indications through supplementary registration pathways.

Clinical Development Timeline

• 2023-12-20: First-in-human urological procedure at Nanjing Drum Tower Hospital
• 2024-03-30: Completed urology registration trial enrollment
• 2024-06: Expanded to hepatobiliary, gastrointestinal, and thoracic surgery FIH procedures
• 2024-08-23: Simultaneous gynecological FIH procedures at two centers
• 2024-09-09: Reached 100th clinical procedure milestone
• 2024-12-05: Completed multi-specialty registration trial enrollment
• 2025-03-26: Received NMPA clearance for urological surgery

Frequently Asked Questions

What surgeries can AGIBOT perform?

AGIBOT has been clinically validated for procedures across urology, hepatobiliary surgery, gastrointestinal surgery, colorectal surgery, gynecology, and thoracic surgery. Initial NMPA approval covers urological surgery indications, with additional specialty approvals being pursued.

How many clinical procedures has AGIBOT completed?

During registration clinical trials between December 2023 and December 2024, the AGIBOT system completed over 130 procedures across multiple surgical specialties at several medical centers in China.

Is AGIBOT available outside China?

As of early 2026, AGIBOT has received regulatory approval only in China (NMPA). The system has not yet obtained CE Mark certification for Europe or FDA clearance for the United States.

How does AGIBOT compare to imported surgical robots?

AGIBOT is a four-arm platform developed entirely through domestic R&D, with Agile Medical Technology maintaining independent intellectual property across mechanical, electrical, optical, and software systems. The system offers features comparable to established platforms including 3D visualization, multi-arm architecture, and fluorescence imaging capability, while potentially providing cost advantages for Chinese healthcare institutions.