AIRS Medical Clears FDA 510(k) for Body-Fat MRI AI

AIRS Medical has won FDA 510(k) clearance for SwiftSight® Body Composition, AI software that turns a single MRI scan of under five minutes into a quantified read on a patient's fat and muscle, the Seoul, South Korea company announced 5 October 2026. SimonMed Imaging, the U.S. outpatient network that already runs AIRS Medical's flagship SwiftMR software across its centers, is named as the first customer set to deploy the newly cleared tool.

SwiftSight Body Composition, in four figures

5 Oct 2026date AIRS Medical announced the FDA 510(k) clearance

<5 minlength of the MRI scan the software analyzes

170+SimonMed Imaging centers already running AIRS Medical's SwiftMR, the network naming the first deployment

2018year AIRS Medical was founded in Seoul, South Korea

Figures from AIRS Medical's 5 October 2026 announcement and SimonMed's own disclosed network size as of its 2026 SwiftMR enterprise deployment.

What a five-minute scan now measures

SwiftSight Body Composition takes a single MRI acquisition — AIRS Medical says under five minutes — and runs it through AI segmentation that separates and quantifies visceral and subcutaneous adipose tissue, evaluates core muscles including the abdominal wall, psoas and paraspinal muscles alongside the quadriceps, hamstrings and adductors, and scores muscle quality through intramuscular fat infiltration, a marker known clinically as myosteatosis. A separate liver-fat read draws three regions of interest, averages them into a proton-density fat-fraction result, and overlays a visual color map. The resulting Body Composition Report combines those measurements with percentile rankings against age- and sex-matched reference populations in one standardized view, rather than leaving a radiologist to eyeball volumes off a stack of images.

Three things the clearance is built around

01

One scan, not several tools

Visceral and subcutaneous fat, bilateral muscle balance and liver fat have historically required separate measurement workflows or dedicated body-composition scanners; SwiftSight Body Composition derives all of them from one MRI sequence AIRS Medical says runs under five minutes.

02

Built to repeat

AIRS Medical's own rationale for the product centers on tracking change over time — a measurement only useful if the exam is fast and practical enough that a patient or health system will actually repeat it.

03

Benchmarked, not just measured

The report scores a patient's results against age- and sex-matched reference populations, giving a percentile rather than a raw number alone — the same reference-population approach competing body-composition MRI tools also use.

SimonMed's network gets the first look

AIRS Medical named SimonMed Imaging as the first customer set to deploy SwiftSight Body Composition. The pairing is not a cold start: SimonMed, one of the largest U.S. outpatient imaging networks, completed an enterprise-wide rollout of AIRS Medical's older SwiftMR scan-acceleration software across more than 170 centers earlier in 2026, after its chief medical and innovation officer said the vendor delivered the most reliable performance across SimonMed's diverse scanner environments. SwiftSight Body Composition extends that existing relationship from faster image acquisition into quantified interpretation of what the image shows, rather than introducing AIRS Medical to a new customer from scratch.

“Body composition becomes more meaningful when people can track change over time, and that requires an exam that is fast and practical to repeat.” Jina Park, Chief Strategy Officer, AIRS Medical — in the company's 5 October 2026 announcement

A field AMRA and Prenuvo already entered

AIRS Medical is not introducing MRI-based body-composition quantification to the U.S. market. AMRA Medical's AMRA Profiler, built on a roughly six-minute whole-body scan, has held FDA clearance for visceral and subcutaneous fat volume, liver fat fraction and thigh muscle volume for several years. Prenuvo offers an FDA-cleared MRI body-composition analysis as part of its whole-body scan service. Medical IP's DeepCatch takes a different imaging modality into the same clinical question, quantifying skin, bone, muscle, visceral and subcutaneous fat and organ volume from whole-body CT. SwiftSight Body Composition's distinction, on AIRS Medical's own account, is coupling that same category of measurement to a shorter, more repeatable MRI protocol and to a distribution network — SimonMed's centers already running AIRS Medical's other software — rather than a wholly new measurement capability.

SwiftSight Body Composition against a cleared field

Product	Modality	What it measures	US status
SwiftSight Body Composition (AIRS Medical)	MRI, under 5-minute scan	Visceral/subcutaneous fat, muscle mass & quality, liver fat	FDA 510(k) cleared, Oct 2026
AMRA Profiler / BCP Scan (AMRA Medical)	MRI, ~6-minute whole-body scan	Visceral/subcutaneous fat volume, liver fat fraction, thigh muscle volume	FDA cleared
Body Composition Analysis (Prenuvo)	MRI, part of whole-body scan service	Visceral/subcutaneous fat, liver fat, skeletal muscle	FDA cleared
DeepCatch (Medical IP)	Whole-body CT	Skin, bone, muscle, visceral/subcutaneous fat, organs, CNS	FDA cleared

From each company's own labelling and public FDA clearance records; not a clinical or accuracy comparison. No competitor's product page is linked.

The imaging-AI category SwiftSight just entered

$1.8B → $20.2B

Global AI-in-medical-imaging market, 2025 actual to 2033 forecast, per Grand View Research.

2025$1.8B

2026$2.5B

2033$20.2B

Sources: Grand View Research, Artificial Intelligence In Medical Imaging Market report · Market Glass, Inc. (formerly Global Industry Analysts), Body Composition Analyzers Market report

Regulatory News outlook

Quantitative body-composition software is a narrow slice of the broader AI-in-medical-imaging category, one already served by AMRA Medical, Prenuvo and Medical IP before AIRS Medical's entry. At an illustrative 1% share of Grand View Research's 2033 forecast, that slice alone would be worth on the order of $200 million a year — a ceiling, not a company-specific projection, for a sub-category still defined by a handful of FDA-cleared products.

How we got here: 1% of Grand View Research's $20.2 billion 2033 AI-in-medical-imaging forecast is roughly $202 million, an illustrative upper bound for the body-composition-quantification sub-category specifically, not an AIRS Medical revenue estimate; the separate Body Composition Analyzers Market figures (bioimpedance and skinfold devices, not imaging AI) are cited only to show that even the older, larger body-composition-measurement category remains well under $2 billion globally.

From a fastMRI contest to a second SwiftSight

AIRS Medical's road to SwiftSight Body Composition

1. October 2018

   AIRS Medical founded

   Founded in Seoul, South Korea, by a team from Seoul National University including CEO Hyeseong Lee, M.D.

2. 2019 – 2020

   fastMRI Challenge results

   AIRS Medical's deep-learning MR reconstruction technology places in the fastMRI Challenge, co-hosted by Facebook AI Research and NYU Langone Health, a formative result behind SwiftMR.

3. 17 November 2021

   First FDA clearance

   FDA 510(k) clearance for SwiftMR, AIRS Medical's first product, after a Q4 2021 commercial launch in Korea.

4. August 2022

   $20M Series B

   AIRS Medical closes a $20 million Series B financing round.

5. July 2024

   $20M Series C

   A further $20 million Series C, led by Shinyoung Securities and BSK Investment, backs international expansion of SwiftMR.

6. 23 September 2025

   SwiftSight-Brain cleared

   FDA 510(k) clearance for SwiftSight-Brain, AIRS Medical's first quantitative-MRI product under the SwiftSight name, covering brain volumetry.

7. 15 April 2026

   SwiftMR OEM clearance

   FDA clears SwiftMR to work alongside OEM deep-learning reconstruction pipelines from scanner manufacturers.

8. 27 April 2026

   SimonMed deploys SwiftMR enterprise-wide

   SimonMed Imaging completes an enterprise-wide SwiftMR rollout across its U.S. network of more than 170 centers.

9. 18 June 2026

   TA Associates invests

   TA Associates announces an undisclosed-amount strategic growth investment in AIRS Medical to back international expansion.

10. 5 October 2026

    SwiftSight Body Composition cleared

    FDA 510(k) clearance announced for SwiftSight Body Composition; SimonMed Imaging named as the first customer to deploy it.

11. Ahead

    A K-number still to post

    FDA's public 510(k) database had not yet indexed the clearance at the time of this article; AIRS Medical has not stated when SimonMed's deployment begins.

What this clearance does not yet settle: AIRS Medical's own total venture funding has been reported inconsistently across outlets, with figures ranging from roughly $38 million to more than $40 million depending on whether a given count includes its earliest seed-stage rounds or TA Associates' 2026 investment, whose size the company has not disclosed. And while SimonMed is named as the first deployment, neither company has published a start date, a site count for the initial rollout, or pricing — so the gap between "first customer named" and patients actually receiving a SwiftSight Body Composition report remains, for now, AIRS Medical's own timeline to keep.

• Clearance: FDA 510(k) for SwiftSight Body Composition, announced 5 October 2026; no K-number yet located in FDA's public database.
• First customer: SimonMed Imaging, already running AIRS Medical's SwiftMR across 170+ U.S. centers.
• Measures: visceral and subcutaneous fat, abdominal/thigh muscle mass and quality, bilateral muscle balance, and liver fat, from one sub-five-minute MRI scan.
• Not yet public: a confirmed FDA K-number, a SimonMed deployment start date or site count, and a reconciled total for AIRS Medical's venture funding to date.

Frequently asked questions

What did FDA clear for AIRS Medical?

A 510(k) clearance, announced 5 October 2026, for SwiftSight Body Composition: AI software that analyzes a single MRI scan of under five minutes to quantify visceral and subcutaneous fat, abdominal and thigh muscle mass and quality, bilateral muscle balance, and liver fat. It is AIRS Medical's second FDA-cleared SwiftSight product, after SwiftSight-Brain cleared in September 2025.

Does FDA's public database already list the clearance?

Not as of this writing. FDA's 510(k) database typically posts new clearances with a lag of several weeks, and this article could not independently locate a K-number for SwiftSight Body Composition in FDA's public records; the clearance rests on AIRS Medical's own 5 October 2026 announcement, corroborated by Diagnostic Imaging, Unite.AI and BioSpace.

Who is deploying SwiftSight Body Composition first?

SimonMed Imaging, the large U.S. outpatient imaging network that already runs AIRS Medical's SwiftMR software enterprise-wide across more than 170 centers, is named as the first customer to deploy the newly cleared Body Composition module.

Is AIRS Medical a public company?

No. AIRS Medical is privately held, founded in October 2018 and headquartered in Seoul, South Korea. It has raised at least $40 million across disclosed venture rounds, including a $20 million Series B in August 2022 and a $20 million Series C in July 2024, and in June 2026 took an undisclosed-amount strategic growth investment from TA Associates.