Carina Laparoscopic Surgical Robot
Known domestically as 海山一® (Haishan Yi), the Carina platform from Ronovo Surgical became China’s first modular laparoscopic surgical robot to achieve NMPA approval in March 2025. The system distinguished itself by obtaining initial registration covering four major surgical specialties—general surgery, thoracic surgery, gynecology, and urology—in a single filing.
Product Overview
Carina emerged from Ronovo’s stealth development phase in February 2023, introducing a modular architecture that departs from conventional single-column surgical robot designs. Where traditional systems mount all robotic arms on a single base unit, Carina distributes its arms across independent mobile carts. This configuration allows surgical teams to position each arm cart separately around the operating table, adapting to specific procedural requirements and operating room constraints.
The platform targets three persistent barriers to surgical robot adoption: limited multi-specialty flexibility, high total cost of ownership, and steep learning curves. By enabling custom arm configurations for different procedures, Carina aims to improve utilization rates compared to systems optimized for narrower applications.
Key Features
Designed for operating rooms where a single-column robot would force awkward arm positioning, Carina distributes its arms across independent mobile carts that reposition around any surgical table configuration.
- Modular Arm Architecture: Independent arm carts with mobile wheels allow flexible positioning without spatial constraints of single-column designs
- Multi-Specialty Coverage: Single platform supports general surgery, thoracic surgery, gynecology, and urology procedures
- Dual Instrument Compatibility: Supports both articulated wrist instruments and straight-shaft instruments, accommodating surgeon preferences
- Compact Footprint: Individual arm carts designed for easier maneuvering in space-limited operating rooms
- Proprietary Technology: Protected by over 200 patent applications globally
Technical Specifications
Designed with a distributed architecture and 200+ patent applications, Carina covers four specialties from a single modular platform supporting both articulated and straight instruments.
| Parameter | Specification |
|---|---|
| Architecture | Modular / Distributed |
| Arm Configuration | Independent mobile carts |
| Instrument Types | Articulated + Straight |
| Specialties Covered | 4 (General, Thoracic, Gynecology, Urology) |
| Patent Applications | 200+ |
Clinical Applications
The Carina platform has demonstrated clinical utility across multiple procedure types during multi-center trials:
General Surgery
- Cholecystectomy
- Gastrectomy
- Low anterior resection for rectal cancer
Thoracic Surgery
- Lobectomy
- Thoracoscopic procedures
Gynecology
- Hysterectomy
- Pelvic procedures
Urology
- Radical prostatectomy
- Iliac lymph node dissection
Clinical trials conducted at multiple centers achieved 100% procedural success rates with no conversions to conventional laparoscopic or open surgery required, according to company disclosures.
Regulatory Status
| Region | Status | Date |
|---|---|---|
| China (NMPA) | Approved | 2025-03 |
| Europe (CE) | Submission Underway | - |
| USA (FDA) | Not Applied | - |
| South America | Submission Underway | - |
The NMPA registration (Certificate No.: 国械注准20253010500) represents the first approval of a modular surgical robot architecture in China. The four-specialty coverage achieved in the initial filing is also a first for the domestic market.
In December 2024, expert consensus guidelines for modular surgical robots in thoracic surgery were initiated based on Carina’s clinical experience, establishing standardized protocols for this emerging device category.
Frequently Asked Questions
What makes Carina different from da Vinci?
Carina uses a modular design with separate mobile arm carts rather than the integrated single-column architecture used by da Vinci systems. This allows more flexible arm positioning around the patient and potentially better adaptation to space-constrained operating rooms. Carina also offers both articulated and straight instrument options.
When did Carina receive regulatory approval?
Carina received NMPA Class III medical device registration in March 2025 (Certificate No.: 国械注准20253010500). It became the first modular surgical robot approved in China and the first to receive initial approval covering four specialties simultaneously.
What is the clinical success rate for Carina procedures?
According to Ronovo Surgical, multi-center clinical trials achieved 100% procedural success rates across all four approved specialties, with no procedures requiring conversion to conventional laparoscopic or open surgery.
Is Carina available outside China?
As of January 2026, Carina is commercially available only in China following NMPA approval. Regulatory submissions are underway in Europe and South America. The company has not announced FDA submission plans.
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Sources
Publicly available references used for the data on this page. See data methodology for verification standards.
