Enhancement agent: registered as a medical device in China. Software: not a registered medical device in any country. Neither is cleared or approved by the U.S. FDA or Health Canada, and neither is currently available in the United States or Canada. Regulatory status
About

AIMED · Aimed Smart Medical

A manufacturer that has been selling the product for years, plus a team doing standardization and software.

Company

Two entities, one product line.

Aimed Smart Medical (Huzhou) Co., Ltd. was established in Huzhou, Zhejiang Province, China, in 2021. It is 85% owned by Huzhou East Asia Pharmaceutical Products Co., Ltd., which manufactures the enhancement agent described on this site and holds its Chinese medical device registration.

That structure is the point rather than a footnote. The enhancement agent has been manufactured and used in China for years. AIMED exists to do the part that was missing: turning a product into a repeatable procedure, and building the software that checks whether the procedure was followed.

EntityRole
Huzhou East Asia Pharmaceutical Products Co., Ltd.Manufacturer of the enhancement agent. Holder of China NMPA Class II medical device registration certificate 浙械注准20212060179 and of the 天下 / TXP trademark. 85% shareholder of AIMED.
Aimed Smart Medical (Huzhou) Co., Ltd. — AIMEDAcquisition procedure, data standardization, and image-quality software.
CollaborationRole
Huzhou First People’s HospitalClinical work and physician review
Nanjing UniversityAlgorithm research
Chinese PLA General HospitalClinical advice
Regulatory

Regulatory status.

The oral gastrointestinal ultrasound enhancement agent described on this website is registered as a Class II medical device in China. It has not been reviewed, cleared or approved by the U.S. Food and Drug Administration or by Health Canada, and it is not currently available in the United States or Canada.

The software described on this website is under development and is used in research data collection and internal validation only. Its established functions assess image quality and acquisition completeness; an analysis layer in development is designed to mark regions for physician review and indicate the type of finding they may represent. It is not a registered medical device in any country and has not been submitted for regulatory review. No layer produces a diagnosis, none is used in clinical reporting, and no clinical decision should be based on its output.

The studies cited on this website were published in the international literature and were conducted in Australia, the United States, Japan and China, each with the population, equipment and operators described in the publication. They are reported as published literature — not as performance claims for any product, and not as evidence of clinical benefit in any other setting.

Descriptions of how the system is used describe deployments in China. This website does not offer pricing, ordering or distribution information for the United States or Canada. Nothing on this website is medical advice.

Contact

Interested, or thinking about working together?

Whether you want to talk about the technology, explore a partnership, or are simply curious how this works — you are welcome to write.

Email

Research collaboration, partnership inquiries, and questions about the work itself.

xiyanzhao919@gmail.com

We are a China-based company and do not currently operate in North America. Partnership and regulatory questions are passed to the appropriate people at the company.

  • We cannot give medical advice. We do not comment on any individual’s condition, examination results or treatment. If you or a family member has a health question, please talk to your doctor.
  • Please do not send patient information. No names, record numbers, or images that have not been de-identified.
  • This is not a sales channel. The products described on this site are not approved or currently available in the United States or Canada; we do not take orders or give quotes.