By Fineline Cube Shanghai Microport EP Medtech Co., Ltd. (SHA: 688351) announced that the National Medical Products Administration (NMPA) has cleared its EasyEcho single-use intracardiac echocardiography (ICE) imaging catheter for market launch. The device represents China’s smallest‑diameter domestically produced ICE catheter and the first to achieve catheter localization and ultrasound modeling functions at reduced diameter.
Regulatory Milestone & Product Profile
| Item | Detail |
|---|---|
| Company | Shanghai Microport EP Medtech Co., Ltd. (688351.SH) |
| Product | EasyEcho single-use intracardiac echocardiography imaging catheter |
| Clearance | NMPA market launch approval |
| Innovation | Smallest‑diameter ICE catheter domestically produced in China |
| Key Features | Catheter localization and ultrasound modeling with small diameter |
| Prior Status | Approved for “green channel” innovative medical devices (April 2025) |
| Design | Catheter + connecting tail wire; vascular delivery to cardiac region |
| Clinical Value | Precise 3D visualization support for intracardiac interventional procedures |
Market Impact & Commercial Outlook
- China ICE Market: Valued at ¥2.5 billion : (~US$350 million) in 2025, growing at 18% CAGR driven by electrophysiology procedure expansion
- Competitive Position: EasyEcho’s small diameter and localization capabilities differentiate from imported ICE catheters (Boston Scientific, Abbott)
- First‑Mover Advantage: First domestic ICE catheter with advanced imaging functions; positions Microport as leader in China’s structural heart imaging segment
- Revenue Potential: Analysts project ¥500–800 million : (US$70–112 million) peak annual sales by 2028, assuming 30% share of domestic ICE market
- Strategic Value: Bolsters Microport’s electrophysiology ecosystem, complementing its ablation catheter and mapping system portfolio
- Next Steps: Commercial launch expected Q2 2026; hospital pilot programs in Tier‑1 cities to commence immediately
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch timelines, market penetration, and revenue projections for EasyEcho. Actual results may differ due to competitive responses, hospital adoption rates, and reimbursement negotiations.-Fineline Info & Tech