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FDA clears AI software that turns MRI scans into body composition analysis

FDA clears AI software that turns MRI scans into body composition analysis

New Capabilities

AIRS Medical's SwiftSight quantifies muscle, fat, and liver fat from a five-minute MRI scan; SimonMed Imaging is first to deploy

October 5th, 2026: AIRS Medical announces clearance

Overview

Updated Oct 8

A five-minute MRI scan can now break down a patient's muscle, fat, and liver fat into measured numbers. The FDA cleared AIRS Medical's SwiftSight Body Composition on October 1, and SimonMed Imaging will run it inside SimonMed Longevity, its self-pay whole-body MRI service.

The software automates what radiologists judge by eye: it quantifies visceral and subcutaneous fat, muscle quality, and liver fat, then benchmarks against reference populations. Two Category III CPT codes track the analysis but do not guarantee payment. Early reports will reach patients through the self-pay program, not insurers.

Why it matters

BMI can't show where fat sits or how much muscle a patient carries; this software turns existing MRI machines into automated body composition analyzers.

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Key Indicators

5 min
MRI scan time
SwiftSight Body Composition runs on a scan under five minutes.
139 days
FDA review time
Traditional 510(k) review from submission on May 15 to clearance on October 1.
1
First deployment customer
SimonMed Imaging will be the first network to deploy the cleared software.
$899
Self-pay whole-body MRI price
SimonMed Longevity sells whole-body MRI scans from $899, with the body composition analysis included.

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People Involved

Ajit Shankaranarayanan
Ajit Shankaranarayanan
Chief Product Officer at AIRS Medical
Leading the SwiftSight quantitative MRI platform
 Jina Park
Jina Park
Chief Strategy Officer at AIRS Medical
Named as the company spokesperson for the SwiftSight Body Composition clearance, citing preventive health, weight management and longevity as target uses

Organizations Involved

AIRS Medical
AIRS Medical
Medical imaging AI company
Developer of SwiftSight Body Composition

Seoul-based company building AI software that speeds up MRI scans and automates quantitative analysis.
SimonMed Imaging
SimonMed Imaging
Medical imaging network
First customer to deploy SwiftSight Body Composition

US-based imaging network that will be the first to deploy the cleared body composition software.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal regulator
Granted 510(k) clearance for K261612

US agency that cleared SwiftSight Body Composition through the Traditional 510(k) pathway.

Timeline

May 2026 October 2026

3 events Latest: October 5th, 2026 · 1 month ago

  1. AIRS Medical announces clearance

    Latest Announcement

    Company announces FDA clearance; SimonMed Imaging named as first deployment customer.

  2. FDA clears SwiftSight Body Composition

    Regulatory

    FDA clears K261612 after 139-day review, finding it substantially equivalent to a predicate device.

  3. 510(k) submitted to FDA

    Regulatory

    AIRS Medical files SwiftSight Body Composition for Traditional 510(k) review.

Scenarios

1

Body composition MRI becomes a standard metabolic health screen

Possible Resolves by End of 2027

Discussed by: AIRS Medical's product roadmap and imaging industry analysts

SimonMed deploys the software across multiple sites, and other imaging networks follow. The quantitative report becomes a standard add-on for preventive imaging, weight management, and healthy-aging programs, creating a new revenue line from existing MRI machines.

2

Stays a self-pay wellness add-on

Possible Resolves by End of 2027

Discussed by: iaica.com.cn analysis of payment and interpretation gaps

Without payer coverage, the service remains a cash-pay option at preventive imaging and longevity clinics. Adoption stays limited to high-end wellness programs, and the technology does not enter routine clinical care pathways.

3

Competitors enter the quantitative MRI market

Likely Resolves by End of 2027

Discussed by: Imaging industry observers tracking the AI MRI segment

Rival AI imaging vendors release similar FDA-cleared body composition tools, commoditizing the category. AIRS Medical's first-mover advantage narrows as the market shifts to price and workflow integration.

4

SimonMed Longevity expands, carrying SwiftSight into more markets

Likely Resolves by Q2 2027

Discussed by: SimonMed's disclosed growth figures

SimonMed Longevity grew from 30 to more than 70 sites by the end of Q1 2026. As the self-pay service adds locations, SwiftSight Body Composition rides along. The open question is whether the resulting scan volume and longitudinal results persuade an insurer to cover the analysis.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

1990

Coronary artery calcium scoring (1990)

Arthur Agatston published a method that quantified coronary artery calcium on CT scans, turning a qualitative image into a numeric risk score. The Agatston score gave cardiologists a reproducible number for cardiac risk.

Then

The score became a widely used research tool for cardiac risk assessment.

Now

It became a standard clinical test, though reimbursement battles lasted years before payers covered it.

Why this matters now

Shows how a quantitative imaging biomarker can move from research to clinical use, and how slowly payment follows the science.

1980s

DEXA bone densitometry (1980s)

Dual-energy X-ray absorptiometry emerged as a way to measure bone mineral density quantitatively, replacing subjective readings of bone loss on plain X-rays.

Then

DEXA became the standard tool for diagnosing osteoporosis and monitoring treatment.

Now

It established quantitative body measurement as a reimbursable clinical service.

Why this matters now

Body composition via MRI is the same kind of quantitative measurement, applied to fat and muscle instead of bone.

Sources

(9)
+3
AIRS Medical Diagnostic Imaging 510k Database AuntMinnie Unite.AI IAICA Regulatory News PR Newswire AIRS Medical