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
In practice

Look at the images, look at the data — and at the limits.

Three things on this page: before-and-after cine loops of the same patient, the published data from Peking Union Medical College Hospital, and the complete literature of this field — including the study whose result runs against ours.

Cine comparison

Before / after.

Same patient, same examination, same scanner. The two loops were recorded about four minutes apart.

Before
Before. Fasting scan; the stomach is not filled. Gas shadowing is visible and limits the view of deeper structures.
After
After. The same patient about four minutes after taking the agent. The stomach is filled with uniformly echogenic content and forms an acoustic window; the pancreatic region behind it can be examined through the stomach.

Two cine loops from one routine examination in China, exported from the scanner without patient information; the scanner’s settings overlay is left as recorded. Trimmed and re-encoded for the web, otherwise unedited. Illustrative of how the acoustic window is established; not evidence of diagnostic performance.

Published study

Peking Union Medical College Hospital, 27 patients.

Published in Quantitative Imaging in Medicine and Surgery in 2024: 27 patients with 30 pancreatic cystic lesions were imaged before and after taking a grain-based oral enhancement agent.

The study was designed, conducted, analyzed and reported by the hospital, and funded by the hospital’s own clinical research program. AIMED’s parent company supplied the agent it used and had no other role — no funding, no authorship, no part in the design, the analysis or the writing. We state this plainly because that independence is the reason the result is worth citing at all.

Satisfactory acoustic window30% before the agent, 80% after — 9/30 to 24/30 (P = 0.002)
Structural visualization scoreImproved (P = 0.001)
Structures newly visibleSepta, wall thickness over 2 mm, papillary structures, calcifications and duct dilatation became observable after the agent in some lesions
Versus non-contrast MRIIn the 21 lesions also examined with MRI, the difference in visualization score did not reach statistical significance — median 1 versus 2 (P = 0.070)

The authors’ own conclusion was a call for further work rather than a claim about the present technique: “Further research to improve visualization of PCLs on TAUS using oral contrast agents could result in TAUS being a potential alternative to MRI in the follow-up of PCLs in resource-limited situations.”

Ji J, Shi X, Xia Y, et al. Quant Imaging Med Surg 2024;14(8):5602–5609. doi:10.21037/qims-24-367. Supported by the National High Level Hospital Clinical Research Funding of Peking Union Medical College Hospital (2022-PUMCH-D-001).

What this study does not establish

It enrolled 27 patients at a single center and compared each patient with themselves before and after, without randomization. A difference that does not reach significance in 21 lesions is not evidence of equivalence — the point estimate favored MRI, and the study reported no formal agreement analysis. It did not compare the agent against plain water, or against simethicone and water with repositioning. It did not evaluate cancer detection, and it was a study of lesions already known to be there. Larger, controlled, multicenter work is what this field needs next.

The full literature

Seven studies, including the one that disagrees with us.

These studies 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.

StudyPopulationIntervention studiedWhat it found
Warren, J Clin Ultrasound 1978—Liquid-filled stomachFirst description of the liquid-filled stomach as an ultrasonic window to the upper abdomen
Lund, Radiology 1992—Cellulose-based oral agentEarly description of cellulose agents for gastrointestinal ultrasound
Abu-Yousef, Radiology 2000n = 70 vs 70Simethicone + 500 mL degassed water + repositioningComplete pancreatic tail visualization 79% vs 7%; window lasted about 10 minutes
Ishigami, Ultrasound Q 201438 healthy volunteersCellulose-coated agent vs simethicone + waterSimethicone and water with repositioning performed better in the supine position
Nakao, Eur J Radiol 2017n = 186Fluid ingestion + seated positionCyst detection 92% vs 70%; pancreatic tail 67% vs 27%
Matsumoto, Intern Med 202420 healthy volunteers500 mL degassed waterWhole pancreas adequately visualized in 55% supine, 75% repositioned, 90% after water
Ji, Quant Imaging Med Surg 202427 patients, 30 lesionsGrain-based oral enhancement agentSatisfactory acoustic window 30% → 80% (P = 0.002)

These studies do not agree with one another, and the one that disagrees with us is in the table. Ishigami and colleagues found that simethicone with water and repositioning performed better than a cellulose-coated agent for pancreatic visualization in the supine position. That study used a different formulation family from ours, enrolled volunteers with normal pancreases, and assessed a single time point rather than a procedure spanning twenty minutes — but those are differences, not refutations, and the head-to-head trial that would settle the question has not been run.

Interested, or thinking about working together?

Research collaboration, distribution partnerships, or simply a conversation about the technology — all are welcome. We do not currently operate in North America, but we are open to the conversation.

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