Cable-transmission architecture
The ultra-flexible cable supports power supply and real-time image transmission between the capsule endoscope and image processor.
Upper GI tract examination
AICAM™ CT-MCCE System
A cable-transmission magnetically controlled capsule endoscopy (CT-MCCE) system combining a disposable sterile capsule endoscope, image processor, and magnetic control device for examination of the esophagus, stomach, and duodenal bulb. Market-specific intended-use wording requires regulatory review.
Founded
2018
Beijing, China
Registration
China Class III
No. 20253060186, review wording pending
Clinical evidence
Published
Gastrointest Endosc. 2025;101:804-817
Market availability
TBD
Varies by country or region
Why this matters
Designed for upper GI tract examination workflows
AICAM is presented as a cable-transmission magnetically controlled capsule endoscopy system. Its combined magnetic and cable control architecture is designed to support visualization across the esophagus, stomach, and duodenal bulb.
Product positioning and intended-use statements remain subject to product and market-specific regulatory review.
System overview
An integrated system combining cable transmission with magnetic control
Published product information describes the CT-MCCE system as comprising a disposable sterile capsule endoscope, an image processor, and a magnetic control device. AICAM model naming and current commercial configuration require product-owner confirmation.
Disposable sterile capsule endoscope
A single-use capsule endoscope with an imaging unit, adjustable LED illumination, a permanent magnet, and an ultra-flexible cable.
Image processor
Receives and processes images captured by the capsule endoscope and supports image display and storage.
Magnetic control device
Includes a support device, cable control device, and magnet control device with a control handle.
Product imagery is suitable for prototype review. Asset ownership and public-use approval remain pending.
Core capabilities
Cable transmission, combined control, and real-time imaging
Terminology below follows the published CT-MCCE clinical article and the supporting device description. Specifications require confirmation against the current commercial model.
Combined magnetic and cable control
External magnetic force and cable retraction or release support control of capsule position and orientation.
Real-time imaging
The clinical-study system used 1280 × 720 imaging at 30 frames per second with adjustable LED illumination.
Upper GI tract observation
The published study evaluated examination and focal lesion detection in the esophagus, stomach, and duodenal bulb.
Examination workflow
Preparation, capsule control, real-time imaging, and reporting
01
Prepare
Complete the site-approved preparation protocol and pre-examination assessment.
02
Swallow
The patient swallows the disposable sterile capsule endoscope after preparation.
03
Navigate
The physician uses the magnetic control device and cable control device to guide capsule position and orientation.
04
Observe
Images are transmitted to the image processor in real time for display and review.
05
Retrieve and report
After examination, the capsule is retrieved through the mouth via the cable, and the physician prepares the examination report.
Published clinical evidence
Prospective multicenter study published in 2025
A prospective, multicenter, self-controlled clinical trial compared CT-MCCE with conventional gastroscopy for upper GI tract examination and focal lesion detection. The study enrolled 180 adults at three hospitals in China.
The authors reported that CT-MCCE completed upper GI tract examinations with diagnostic performance comparable to EGD in the study setting, with a lower incidence of discomfort and no observed adverse events.
Study at a glance
- Design: prospective, multicenter, self-controlled clinical trial
- Comparator: conventional gastroscopy
- Study areas: esophagus, stomach, and duodenal bulb
- Clinical trial registration: ChiCTR2200063630
Tian Y, Du S, Liu H, et al. Gastrointest Endosc. 2025;101(4):804-817. doi:10.1016/j.gie.2024.07.028. Results should be interpreted within the enrolled population, study protocol, and stated limitations.
Application contexts
Designed for healthcare and partnership workflows
Scenario wording should be narrowed after intended use and market claims are reviewed.
Hospitals and gastroenterology departments
Upper GI tract examination workflow messaging remains subject to intended-use and market review.
Health screening centers
Screening workflow and claims require market-specific and regulatory confirmation.
Distributor and channel partners
Partner positioning, training support, and regional availability details are pending business confirmation.
Regulatory and market availability
Market-specific claims must remain separated
Current materials include China registration information and a 2024 draft U.S. Breakthrough Devices Designation request. The request is a terminology source only and does not establish FDA designation, clearance, approval, or U.S. availability.
Market
Prototype status
China
Class III registration referenced in source file. Public wording pending regulatory review.
United States
A draft designation request is on file. Designation outcome, FDA clearance or approval, and U.S. availability are not confirmed.
European Union
TBD. Do not imply CE/MDR status or availability.
Product availability and regulatory status vary by market. Please contact Shanxing Medical for market-specific information. Final disclaimer requires regulatory review.
Company
Shanxing Medical is focused on upper GI tract examination solutions
Founded in 2018 in Zhongguancun, Beijing, Shanxing Medical develops medical-device solutions for upper GI tract examination and screening workflows. Institutional, award, and project references require source review before publication.
Headquarters: Beijing, China
Quality system details: Pending certificate confirmation
Patents and awards: Pending source files
Partner inquiry
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