Assertion Supported AI assessment confidence: 95% certainty 4/5 debate potential 1/5

Jackie DeMarco: FDA cleared IMAGExRAY device for infants over four weeks

Jackie DeMarco · Revolutionizing Dysphagia Diagnosis: IMAGExRAY’s Technology is Transforming Healthcare · Jun 10, 2025 · at 8:29

Jackie DeMarco, co-founder of Image X-Ray, explains how the company expanded its dysphagia imaging technology from adult patients into pediatric care.

0:00 / 0:08exact quote · 8.1s

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“And during the FDA process, they said, okay, you can use it on babies aged four weeks and older.”

quote is from the automated transcript, cleaned for reading: filler sounds and stutters are removed, nothing is rephrased. names can be misheard (the analysis reads context, assessments check outside sources). how →

The claim, plainly

The FDA approved Image X-Ray's diagnostic imaging device for use on infants aged four weeks and older.

a quote alone can be ambiguous, so this restates it with the references and context of the conversation around it resolved. AI-written; the tape below the player is the source.

Assessment

FDA 510(k) clearance records for IMAGExRAY, LLC's VFSS Pro Mobile Digital Imaging System (K212523, cleared November 5, 2021) explicitly permit usage across both general and pediatric applications on all patients 'except neonates (birth to one month)'. Excluding neonates aged birth to one month directly corresponds to permitting use on infants aged four weeks (one month) and older.

FDA 510(k) clearance summary K212523 (cleared November 5, 2021) for IMAGExRAY, LLC's VFSS Pro Mobile Digital Imaging System explicitly states the device is indicated for pediatric patients 'except neonates (birth to one month)'.

Checked against

[1] fda.gov [2] fda.gov [3] fda.gov [4] fda.report [5] fda.gov [6] fda.gov [7] fda.gov [8] fda.gov

"K212523" FDA "Indications for Use" OR "neonates" OR "infants" "IMAGExRAY, LLC" "K212523" FDA 510k "IMAGExRAY" OR "Image X-Ray" "VFSS Pro Mobile Digital Imaging System" "IMAGExRAY" site:accessdata.fda.gov "IMAGExRAY"

assessed as of 2026-09-02

This assessment is an AI reading of a public statement, made against the cited references with the confidence shown. It can be wrong. The quote, the tape and the references are all on this page; if something is off, use report an error below. full disclaimer →

Mentioned

FDA IMAGExRAY

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Assertion Supported

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Assertion Contradicted

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Jackie DeMarco: FDA cleared IMAGExRAY device for infants over four weeks

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