Eight Innovative Medical Devices Enter Special Review Process, Companies File IPO Prospectuses

Sep 05, 2025 17:40 CST Updated 17:40

ScieHome

Developer of Ultrasound Energy Technology and Pharmaceutical-Device Combination Technology

Balance Medical

Producer of Cardiovascular Disease Implant Devices and Surgical Soft Tissue Repair Materials

Mindray

Medical Device R&D Manufacturer

AK Medical

Medical Device R&D Manufacturer

SceneRay

Innovative High-Tech Medical Device R&D and Manufacturer

CMDE Releases "Announcement of the Review Results for Special Examination Applications for Innovative Medical Devices (No. 8, 2025)", Proposing to Approve the Following Application Projects to Enter the Special Examination Process. The announcement period is from September 5, 2025, to September 19, 2025. Details are as follows:

1. Product Name: Ultrasonic Thrombolysis Device and Single-Use Ultrasonic Thrombolysis Catheter

Applicant: ScieHome

2. Product Name: Radiofrequency Ablation System

Applicant: Beijing Balance Medical Technology Co., Ltd.

3. Product Name: Adjustable Diameter TIPS Covered Stent System

Applicant: MEImedical

4. Product Name: Magnesium Alloy Hollow Bone Screw

Applicant: Suzhou Innova Medical Technology Co., Ltd.

5. Product Name: Anesthesia System

Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

6. Product Name: Hip Joint Prosthesis Components

Applicant: AK Medical Holdings Limited