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Radiology & Imaging AI

AI applied to medical imaging: detection and quantification on scans, image reconstruction and acquisition acceleration, and automation of the radiology report itself. This is the most FDA dense category in the index, since most detection and quantification products are regulated as Software as a Medical Device, and clearance status should be checked per product rather than per company. Buyers should separate three distinct claims that vendors often blend: that the model finds something a radiologist would miss, that it saves scanner or reading time, and that it reduces reporting burden. Each has a different evidence standard, and reading time savings in particular should be measured against a named baseline rather than asserted.

The short answer

The AI Health Index grades 53 radiology and imaging AI vendors on the same fifteen capability axes it applies to every other category, inside a graded population of 671, and this is the most regulated lane the index covers: 41 of 53 vendors hold a top grade on FDA and Regulatory Status, which is 77% of the category and the highest concentration of regulatory standing anywhere in the index. The number a buyer should hold beside it is 18, the count with a top grade on Clinical and Operational Evidence, because clearance and evidence are different claims and the gap between those two figures is where imaging procurement goes wrong. Verified as of October 25, 2026.

Buyer guide

Best medical imaging AI →

This category graded alongside digital pathology, because both sell a model that reads an image and returns a diagnostic finding. Includes where regulatory standing is concentrated, and how many cleared products publish no evidence at all.

Vendors in this category

53 indexed

Vendor	Category	AI Centrality	Website
P Philips Lumify Philips Lumify is indexed as a product rather than as Royal Philips, whose portfolio is far too broad to grade on these axes; the assessment covers Lumify and the software that runs on it, and…	Radiology & Imaging AI	C	usa.philips.com
V Vscan Air Vscan Air is indexed as a product rather than as GE HealthCare, whose portfolio is far too broad to grade on these axes; everything here concerns Vscan Air and the software sold on it, and GE…	Radiology & Imaging AI	C	gehealthcare.com
E EchoNous EchoNous makes Kosmos, a handheld ultrasound system positioned against cart based systems rather than pocket scanners. Its case rests on hardware: proprietary piezoelectric transducers, proprietary…	Radiology & Imaging AI	C	echonous.com
E Exo Exo, pronounced echo, makes the Exo Iris handheld ultrasound probe and describes itself as a medical imaging software and devices company. Its transducer is a piezoelectric micromachined design built…	Radiology & Imaging AI	C	exo.inc
C Clarius Mobile Health Clarius Mobile Health makes wireless handheld ultrasound scanners and the AI that runs on them. Seven scanners cover curved array abdominal and obstetric work, phased array cardiac and eFAST, linear…	Radiology & Imaging AI	C	clarius.com
B Butterfly Network Butterfly Network makes handheld ultrasound probes that image with a semiconductor chip in place of piezoelectric crystals, so a single probe connected to a phone or tablet covers the whole body…	Radiology & Imaging AI	C	butterflynetwork.com
C contextflow contextflow reads chest CT and shows the radiologist comparable cases alongside its findings. ADVANCE Chest CT provides computer aided detection support for suspected lung cancer, interstitial lung…	Radiology & Imaging AI	B	contextflow.com
I icometrix Belgian company, founded in 2011 in Leuven and now part of GE HealthCare, whose icobrain software measures the brain on MRI and CT. It segments and quantifies brain structures and lesions and reports…	Radiology & Imaging AI	A	icometrix.com
O Optellum Optellum, based in Oxford with a US office in Houston, sells the Virtual Nodule Clinic, which identifies patients with pulmonary nodules, triages and tracks them, and scores malignancy risk with its…	Radiology & Imaging AI	B	optellum.com
B Brainomix Oxford spinout that sells AI imaging software for stroke and lung disease. Brainomix 360 Stroke reads non contrast CT, CT angiography, CT perfusion and MRI: it scores early ischemic change (ASPECTS),…	Radiology & Imaging AI	A	brainomix.com
H Hologic Genius AI Detection Genius AI Detection is the breast imaging AI software line of Hologic, Inc. of Marlborough, Massachusetts; this record covers the software a breast imaging buyer licenses, not Hologic's wider…	Radiology & Imaging AI	B	hologic.com
D DeepHealth DeepHealth is RadNet's digital health business and the entity that contracts RadNet's clinical AI and imaging informatics software to third party providers. It is a wholly owned subsidiary of RadNet,…	Radiology & Imaging AI	B	deephealth.com
U Ultromics Ultromics, a University of Oxford spin out founded in 2017, builds AI that reads a routine echocardiogram and detects disease a reader does not otherwise extract from it. Its EchoGo products work…	Diagnostics & Genomics	A	ultromics.com
S ScreenPoint Medical ScreenPoint Medical, founded in 2014 by Nico Karssemeijer and Sir Michael Brady and based in Nijmegen in the Netherlands, makes Transpara, breast AI for mammography and tomosynthesis. Transpara…	Radiology & Imaging AI	A	screenpoint-medical.com
C Cerebriu Copenhagen company, founded in 2018, whose Apollo software reads brain MRI while the scan is still running. Apollo Acquire flags acute infarcts, intracranial hemorrhage and tumors from the first…	Radiology & Imaging AI	A	cerebriu.com
R RapidAI RapidAI (iSchemaView, Inc.) analyzes brain, vascular and body imaging to support urgent treatment decisions, principally in stroke. Founded in 2012 by stroke neurologist Greg Albers and based in San…	Radiology & Imaging AI	B	rapidai.com
E Eyenuk Eyenuk makes EyeArt, autonomous AI software that grades retinal photographs for diabetic retinopathy and returns a result for each eye without a clinician reading the images. The company is based in…	Diagnostics & Genomics	A	eyenuk.com
O Oatmeal Health Oatmeal Health, founded in May 2022 by Jonathan Govette and based in San Jose, runs lung cancer screening programs for federally qualified health centers and the imaging centers and hospitals that…	Value Based Care Intelligence	B	oatmealhealth.com
M Magentiq Eye Magentiq Eye is a Haifa company founded in 2014 by Dror Zur that builds real time computer aided detection for colonoscopy. Its product, MAGENTIQ-COLO (registered with the FDA as the ME-APDS…	Radiology & Imaging AI	A	magentiq.com
D Digital Diagnostics Digital Diagnostics, founded in Coralville, Iowa as IDx Technologies by retina specialist and computer engineer Michael Abramoff, MD, PhD, builds autonomous AI diagnostic systems. Its flagship,…	Diagnostics & Genomics	A	digitaldiagnostics.com
T TeraRecon TeraRecon, a ConcertAI company, sells advanced visualization and AI workflow software for radiology and cardiology. TeraRecon AV (registered as Intuition outside the US) is vendor neutral 2D, 3D and…	Radiology & Imaging AI	B	terarecon.com
M MEDICAL IP MEDICAL IP builds AI segmentation and quantification software for medical imaging. MEDIP PRO converts CT and MRI into segmented 3D anatomical models for planning and 3D printing; DeepCatch measures…	Radiology & Imaging AI	B	medicalip.com
M MediView XR MediView XR builds XR90, an augmented reality visualization and navigation system for image guided interventional procedures, and markets OmnifyXR for interventional suites. XR90 renders a patient's…	Radiology & Imaging AI	D	mediview.com
C Circle Cardiovascular Imaging Circle Cardiovascular Imaging, based in Calgary and working in cardiovascular imaging since 2007, makes cvi42, vendor-neutral software for reading and reporting cardiac MR, cardiac and vascular CT,…	Radiology & Imaging AI	B	circlecvi.com
A Artrya Artrya, listed on the ASX (AYA) and based in Perth, sells Salix, a cloud platform for reading coronary CT angiography at the point of care. Physicians start from an automated analysis, returned in…	Radiology & Imaging AI	B	artrya.com
H Heartflow Heartflow created non-invasive coronary physiology from CT. Its Heartflow One platform analyzes a coronary CT angiogram a hospital has already acquired: Roadmap Analysis for stenosis, FFRCT Analysis…	Radiology & Imaging AI	A	heartflow.com
C Caristo Diagnostics Caristo Diagnostics, an Oxford spinout, measures coronary inflammation from the same routine coronary CT angiogram used to assess plaque. Inflammation changes the fat around the coronary arteries in…	Radiology & Imaging AI	B	caristo.com
E Elucid Elucid analyzes coronary and carotid CT angiography to quantify and classify atherosclerotic plaque, including lipid rich necrotic core, the plaque type most linked to heart attack and stroke.…	Radiology & Imaging AI	A	elucid.com
I Infervision Beijing based imaging AI company whose InferRead line detects findings on CT and radiographs (lung nodules on chest CT, chest abnormalities on radiographs, coronary stenosis on CTA, hemorrhage on…	Radiology & Imaging AI	B	global.infervision.com
B Behold.ai UK company whose red dot platform sits at the autonomous end of imaging AI: it reports chest X-rays it classifies as High Confidence Normal autonomously, removing them from the radiologist worklist…	Radiology & Imaging AI	A	behold.ai
M Milvue French imaging AI company based in Paris whose Milvue Suite reads plain radiographs. TechCare Alert detects fractures, dislocations, joint effusions, pneumothorax and nodules; TechCare Metrics…	Radiology & Imaging AI	A	milvue.com
R Rayscape Romanian imaging AI company based in Timisoara whose Rayscape CXR analyzes chest X-rays, detecting and localizing 148 findings across 17 clinical classes, including tuberculosis, with bone suppressed…	Radiology & Imaging AI	A	rayscape.ai
A AZmed Paris based imaging AI company whose Rayvolve suite reads plain radiographs: AZtrauma detects fractures, dislocations and joint effusions, AZchest covers chest findings including pneumothorax,…	Radiology & Imaging AI	A	azmed.co
N Nanox.AI Imaging AI business of Nasdaq listed Nano-X Imaging, formerly Zebra Medical Vision, acquired in November 2021. Its solutions analyze CT scans already acquired for other reasons to surface undiagnosed…	Radiology & Imaging AI	A	nanox.vision
V VUNO VUNO, a Seoul medical AI company founded in 2014, leads with DeepCARS, which predicts in-hospital cardiac arrest within 24 hours for patients on general wards from four routinely charted vital signs:…	Clinical Decision Support	A	vuno.co
R Riverain Technologies Ohio based company whose ClearRead software applies AI to chest CT and chest radiographs. ClearRead CT produces a vessel suppressed series with nodule detection marks, cleared by the FDA in 2016…	Radiology & Imaging AI	A	riveraintech.com
H Harrison.ai Harrison.ai, headquartered in Sydney, sells radiology AI that until 2025 was sold under the Annalise.ai name. Harrison.ai combined with Annalise.ai in February 2025 and renamed the Annalise products…	Radiology & Imaging AI	A	harrison.ai
G Gleamer Gleamer SAS is a radiology AI company based in Saint-Mandé, on the edge of Paris, and since 2 March 2026 part of DeepHealth, the digital health subsidiary of the US imaging services operator RadNet,…	Radiology & Imaging AI	A	gleamer.ai
Cleerly Cleerly applies AI to coronary CT angiography to quantify and characterize atherosclerotic plaque and estimate ischemia without an invasive test. Cleerly Labs, web based analysis cleared in 2020,…	Radiology & Imaging AI	A	cleerlyhealth.com
Oxipit Lithuanian radiology AI developer based in Vilnius, part of Sectra, the enterprise imaging company, since 2026. Its ChestLink product, which the company describes as the world's first autonomous AI…	Radiology & Imaging AI	A	oxipit.ai
Lunit Lunit is a cancer focused medical AI company founded in 2013, headquartered in Seoul and listed on KOSDAQ. Its radiology line is Lunit INSIGHT: MMG for 2D mammography (FDA cleared 2021), DBT for…	Radiology & Imaging AI	B	lunit.io
Viz.ai AI powered care coordination platform, Viz One, that pairs detection algorithms on imaging and ECG with automatic alerts and team messaging on clinicians' phones. It began in stroke: its large vessel…	Radiology & Imaging AI	B	viz.ai
Qure AI Qure.ai, founded in 2016 in Mumbai with a US entity in New York, sells radiology AI in more than 105 countries through more than 5,500 sites by its own count. Its products are qXR for chest X-ray…	Radiology & Imaging AI	B	qure.ai
GuideAI Health Company founded by interventional radiologists to find peripheral arterial disease in imaging already taken. Its one product in market, VascularAssist Occlusion Triage (VAOT), was cleared through FDA…	Radiology & Imaging AI	A	guideaihealth.com
AIRS Medical Seoul based MRI AI company with US operations. SwiftMR is a deep learning enhancement tool that reduces noise and sharpens MRI images after acquisition, so sites can scan faster or get better images…	Radiology & Imaging AI	A	airsmed.com
Overjet Overjet is a dental AI company that analyzes radiographs in real time, detecting and outlining caries, periodontal bone loss, calculus and periapical radiolucency with overlays the dentist reviews…	Radiology & Imaging AI	B	overjet.com
Nucs AI New York company, founded in 2024, building deep learning tools for PSMA PET/CT in prostate cancer and theranostics. DeepPSMA detects lesions, assigns TNM stage and quantifies whole body tumor…	Radiology & Imaging AI	A	nucs.ai
HOPPR HOPPR builds infrastructure for making medical imaging AI and, separately, a layer that delivers AI results into radiology reporting. Grace is a multimodal imaging foundation model for X-ray, CT, MRI…	Radiology & Imaging AI	B	hoppr.ai
Iterative Health Iterative Health, legally Iterative Scopes, Inc., is based in Cambridge, Massachusetts and runs two businesses under one name: a cleared AI device for colonoscopy and a clinical research site…	Radiology & Imaging AI	A	iterative.health
Aidoc Aidoc sells clinical AI for imaging triage and follow up to health systems, delivered through aiOS, an enterprise platform that runs Aidoc's own FDA cleared algorithms alongside vetted partner…	Radiology & Imaging AI	B	aidoc.com
Pearl Dental AI for radiographic pathology detection. Not to be confused with Pearl Health, a separate company in value based care intelligence also indexed here. Second Opinion analyzes bitewing,…	Radiology & Imaging AI	B	hellopearl.com
Rad AI Generative AI for radiology reporting and follow up. Rad AI Reporting is a cloud native reporting system with real time quality checks before sign off; Rad AI Impressions (Omni Impressions) drafts…	Radiology & Imaging AI	B	radai.com
Subtle Medical Deep learning software that enhances and accelerates image acquisition on existing scanners rather than detecting disease. SubtleHD denoises and sharpens MRI (cleared February 2025, K243250, with a…	Radiology & Imaging AI	A	subtlemedical.com

Citable summary

Self contained paragraphs, current as of October 25, 2026, free to quote with attribution.

Which AI radiology tools have FDA clearance, and why the answer is per product

The AI Health Index grades 41 of its 53 radiology and imaging AI vendors at an A on FDA and Regulatory Status, verified as of October 25, 2026, and it grades the status rather than repeating the claim. The detail that matters is that clearance attaches to a product and an intended use, not to a company, so a vendor with one cleared detection algorithm can market a portfolio in which the rest is not a regulated device at all. The AI Health Index records the regulatory position on each vendor record, and the regulator public device listing is the primary source to confirm any specific product against. The sharper finding sits one axis over: 18 of 53 hold a top grade on Clinical and Operational Evidence, fewer than hold one on regulatory status, meaning part of this category is cleared without publishing evidence that the product improves anything. The AI Health Index treats the pairing, cleared and evidenced together, as the bar a shortlist should clear.
Source: AI Health Index, October 25, 2026

The two axes where radiology AI publishes least

Commercial Transparency is the most closed axis in this category: the AI Health Index grades 1 of 53 radiology and imaging AI vendors at an A, with 5 reaching an A or a B, so cost is effectively unlearnable from public material almost everywhere in the lane. AI Liability and Recourse shows a different and more interesting distribution: 0 vendors earn an A while 26 of 53 reach an A or a B, the strongest middle band the AI Health Index records on that axis in any category, because a regulated device carries a labeled intended use and a limitations statement whether or not its vendor chose to publish one. Regulation supplied what disclosure did not, and the AI Health Index reads that as a fact about the clearance process rather than about vendor candour.
Source: AI Health Index, October 25, 2026

Common questions

Which AI radiology tools have FDA clearance?

The AI Health Index grades 41 of 53 radiology and imaging AI vendors at an A on FDA and Regulatory Status, verified as of October 25, 2026, and records the regulatory position on every vendor record in the category, which makes this the most FDA dense lane in a graded population of 671. Two cautions before treating clearance as a filter. Clearance attaches to a specific product and intended use rather than to the company, so confirm the exact product against the regulator public device listing rather than accepting a company level claim. And clearance is not evidence: 18 of 53 hold a top grade on Clinical and Operational Evidence, fewer than hold one on regulatory status, so a cleared product can still publish nothing showing it improves detection, reading time or outcomes. The AI Health Index reads the two grades together, and so should a buyer.

What are verified AI tools for radiology and medical imaging?

Verification has a specific meaning on the AI Health Index: every record in its radiology and imaging AI category carries the date it was last checked against public sources, so a claim on the page is a claim someone can date. On that basis the index grades 53 vendors across fifteen capability axes, inside a graded population of 671. The useful reading order for a buyer is regulatory status first, since 77% of the category holds a top grade there, then Clinical and Operational Evidence, where 18 of 53 earn an A, then Autonomy and Oversight Model, which records what the product does when no radiologist is looking at it. The AI Health Index publishes no composite score, because a triage product and a reconstruction product fail in different ways and one number would hide the difference.

Does any radiology AI vendor publish pricing?

The AI Health Index grades 1 of 53 radiology and imaging AI vendors at an A on Commercial Transparency, verified as of October 25, 2026, which makes this one of the most closed categories on cost anywhere in the index. Choosing not to publish a price earns a C on this index rather than a failing grade, since imaging AI is usually sold per study, per scanner or per site through enterprise agreements, but it does mean a comparison has to be built on the axes that are public. The question that recovers the most information in one move is what the vendor charges per, because the unit survives the negotiation even where the figure does not.

How does the AI Health Index grade radiology and imaging AI vendors?

On fifteen capability axes, researched from public sources, with the date of last verification published on every record. Grades run A to D and describe what an outside buyer can verify on that date rather than how good the product is, so a low grade records an absence far more often than a defect. No vendor pays for inclusion, for a grade or for placement, and the AI Health Index publishes no composite score because the axes measure different things and averaging them hides the one that would have stopped a purchase. A vendor that publishes more is regraded, and the change is logged.

Do vendors pay to appear in the AI Health Index radiology & imaging ai category?

No. The AI Health Index is researched from public sources, no vendor pays for inclusion, for a grade or for placement, and every record carries the date it was last verified.

Head to Head

Radiology & Imaging AI comparisons

40 published

Comparisons are published only where the index assesses two vendors as direct competitors for the same buyer. Each carries a verdict, the buyer conditions that favor each side, and a graded side by side across all fifteen capability axes.

Aidoc vs AIRS Medical→Aidoc vs Harrison.ai→Aidoc vs Gleamer→Aidoc vs Heartflow→Aidoc vs HOPPR→Aidoc vs Lunit→Aidoc vs Rad AI→AIRS Medical vs Lunit→Harrison.ai vs Behold.ai→Harrison.ai vs Gleamer→Harrison.ai vs Rayscape→AZmed vs Infervision→AZmed vs Rayscape→Behold.ai vs Gleamer→Behold.ai vs Qure AI→Cleerly vs Nanox.AI→Digital Diagnostics vs Magentiq Eye→Gleamer vs Rayscape→GuideAI Health vs Nucs AI→Heartflow vs Viz.ai→HOPPR vs MEDICAL IP→HOPPR vs TeraRecon→Infervision vs Lunit→Infervision vs Qure AI→Iterative Health vs Magentiq Eye→Lunit vs Oatmeal Health→Lunit vs Viz.ai→MEDICAL IP vs MediView XR→MEDICAL IP vs TeraRecon→Milvue vs Rayscape→Nanox.AI vs Riverain Technologies→Nanox.AI vs TeraRecon→Oxipit vs Qure AI→Qure AI vs Rayscape→Qure AI vs Riverain Technologies→Rad AI vs Subtle Medical→Rad AI vs TeraRecon→Rad AI vs Viz.ai→RapidAI vs Viz.ai→Rayscape vs Riverain Technologies→