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
Innovation

What is old here, and what is new.

Saying it precisely is more useful than saying it big. The table further down takes “oral ultrasound contrast” apart into six layers and says, layer by layer, which were done long ago and which are still open.

Why ultrasound at all

Where each method sits.

Line the methods up first, and see which gap ultrasound actually fills.

MethodWhat it showsMain limitationCan it be repeated?
GastroscopyDirect view of the gastric mucosa, with biopsy. The confirmatory test for gastric disease, and the method with the highest detection rate for early gastric cancer.Invasive, often sedated, poor compliance; does not image the pancreas.Yes, but most people are reluctant to repeat it
Endoscopic ultrasound (EUS)One of the most detailed views of the pancreas; allows sampling.More invasive; needs a specialist and dedicated equipment.Not suited to repeated use in people without symptoms
CTWhole-abdomen cross-sections; good pancreatic detail.Ionizing radiation and iodinated contrast.Not suited to frequent repetition
MRI / MRCPGood detail of the pancreas and its duct, no radiation; the standard for follow-up of pancreatic cystic lesions.Expensive, slow, limited availability; some patients cannot have it.Yes, but at high cost
Transabdominal ultrasoundInexpensive, radiation-free, portable, available almost everywhere.The acoustic window problem often leaves the pancreas incompletely seen; cannot confirm a diagnosis; no guideline lists it as a first-line method for pancreatic screening or surveillance.Yes, with almost no limit

Only one row in that table can be repeated as often as needed. Transabdominal ultrasound cannot confirm a diagnosis, and we do not claim that it can — but it is the only imaging method that is inexpensive, radiation-free and repeatable. Its problem has never been whether it can be done. It is whether, once done, anything can be seen.

Our work is aimed at exactly that. And its most immediate use is specific: people with a known pancreatic cystic lesion need follow-up imaging every one to two years, for many years, and the current standard for that is MRI. The question the Peking Union Medical College Hospital study raised is precisely whether, where resources are limited, enhancement-agent-assisted ultrasound could become an option for that follow-up. It is a question worth answering, and it is the one the next studies need to answer.

Layer by layer

Six layers: four old, two new.

This layerNew?Basis
Filling the stomach with liquid as an acoustic windowOldDescribed by Warren in 1978 (Australia)
Cellulose-based oral ultrasound agentsOldLund, Radiology 1992
A commercial oral ultrasound agentOldSonoRx, approved by the FDA in 1998 (as a drug, under an NDA); approval withdrawn in 2009 at the manufacturer’s request after the product ceased to be marketed
Turning the category into established clinical practiceAbandoned in the West, achieved in ChinaThe West’s one approved product left the market in 2009 and radiology moved to CT and MRI. China developed several registered manufacturers, a 2020 expert consensus (Shanghai edition), a structured reporting system and a national standard now in drafting — only China has done this
An oral agent optimized specifically for the pancreatic acoustic windowNewNo product on the market, no registered trial, no new formulation patent since 2020
Oral agent × transabdominal ultrasound × acquisition-quality software × pancreasNewNo paper, product or company found in the public record
Why the West doesn’t have it

Not that no one thought of it — the road was abandoned in the West.

The United States has approved exactly one oral gastrointestinal ultrasound agent: SonoRx, a simethicone-coated cellulose preparation drunk by the patient to fill the stomach. It was approved by the FDA in 1998 — through a New Drug Application, as a drug rather than a device — and its approval was withdrawn in 2009 at the manufacturer’s own request, because the product was no longer being sold.

After that, when bowel gas obscured the upper abdomen, the Western answer was to change modality: CT, or MRI. That works in a well-resourced health system. It does not scale, and it is not cheap.

China took a different path. The category did not disappear; it grew into a full industry with several registered manufacturers, an expert consensus, a structured reporting system and a national standard under development. AIMED grew out of that industry.

What is new

Three things together are what is new.

01 — A DIFFERENT FORMULATION FAMILY

Grain-based, not cellulose-based

What was tried historically was simethicone-coated cellulose (the SonoRx family). This agent is grain-powder-based — an entirely different formulation family. That does not mean “better” (there is no head-to-head data), but it is a distinct technical route.

02 — A DIFFERENT TARGET ORGAN

Aimed at the pancreas, not the stomach

Existing oral agents were nearly all designed for imaging the gastric wall. The pancreas is a different problem: it needs a low-attenuation medium the beam can pass through. No oral medium designed and commercialized for the pancreatic acoustic window exists internationally.

03 — A DIFFERENT TREATMENT OF TIME

Anchored to the moment of ingestion, not the clock

Every clip is indexed as τ = t − t₀, where t₀ is the moment the patient finishes drinking. Gastric emptying varies between people; wall-clock time makes different patients’ images incomparable. This design is at the core of the related invention patent.

A question we have not resolved ourselves

Seeing the gastric wall calls for a uniformly echogenic filling that sets off the wall’s layers; opening a window onto the pancreas calls for a low-attenuation, near-transparent medium the beam can pass through. Those two requirements may pull in opposite directions. We think it is worth saying so — whichever way the answer turns out: one formulation that satisfies both, or two.

Intellectual property

Granted and pending.

Granted invention patent (China)ZL202311416732.4 — AI-based ultrasound contrast diagnostic support system
Pending invention patentAcoustic-window state assessment and examination process control method and system
Software copyrights (China)Image quality control and annotation; data de-identification and quality governance; others registered
Registered trademark (China)天下 / TXP

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.

Contact us