Company and Stock Identity
How Qure.ai Connects to the Public Market
- Company structure
- Private company
- Market access
- No current public listing was verified.
- Research focus
- Ask which of the cleared indications covers the exact finding and the exact scan type you want. Qure.ai spans chest X-ray, CT, stroke care and a clinical decision support product, and a clearance for one finding is not validation for the rest of the list. Its Aira product carries a European CE certification, which is a different approval from an FDA clearance.
No ownership change was found. Checked on 2026-10-10 against the company's own newsroom, where the 2026 items are leadership hires, partnerships and clearances rather than a sale or a listing.
Open the public company market data feed for the full directory, ownership relationships, stock identifiers, and dated snapshots.
First-Hand Company News
Latest Developments
Qure.ai says its Aira decision support tool won a Class IIb CE certification in Europe
Qure.ai said on 17 September 2026 that its clinical decision support system Aira received Class IIb CE certification under the European Union Medical Device Regulation, and the company describes it as among the first in the world to hold that certification for this kind of product. The announcement does not mention any FDA status for Aira.
Why it matters: A Class IIb certification in Europe is a real step up from the risk class that covers triage software, and it tells a European health service that the product was reviewed for a decision support role. It says nothing about the United States, where Aira is not described as cleared, so an American buyer should not read this as an FDA decision. Qure.ai's chest X-ray products and Aira are governed by separate approvals, and the paperwork does not transfer between them.
Qure.ai gets six more FDA clearances for its qXR-Detect chest X-ray tool
Qure.ai said on 26 February 2026 that the FDA granted 510(k) Class II clearance to qXR-Detect, software that finds and sorts chest X-ray findings across six areas: lung, pleura, mediastinum and hila with the heart, bone, hardware, and other findings. The company says the six new indications bring its total to 26 FDA-cleared indications across nine products.
Why it matters: Most radiology AI is bought one finding at a time, so a single cleared product that reports across six areas of the same image can replace several contracts and several integrations. The count is a measure of regulatory paperwork, not of accuracy, and a buyer still has to see the performance data for each finding separately. A tool cleared to detect is also not the same as a tool cleared to triage, so the workflow it slots into matters as much as the list of indications.
Careers and Qualifications
What to Know Before Applying
Work areas: The careers page groups work into engineering, client success, business development, design and marketing, and links out to a separate job board for current openings.
Qualification signal: Deployment experience counts more than model building here. Qure.ai runs screening programs inside public health systems in several countries, so people who have made imaging AI work in a real hospital network are the scarce hire.
Check current roles at Qure.ai. A careers page is the source of record for openings. This profile does not claim a role is open unless the company lists it now.
Related Healthcare AI Roles
- Imaging Informatics Specialist
- Clinical Validation Specialist
- Regulatory Affairs Specialist, Software as a Medical Device
Training to Compare
- Data Science Institute resources and AI certification work ... American College of Radiology
- Imaging AI education program ... Radiological Society of North America
- Deep Learning Institute healthcare and imaging courses ... NVIDIA
Buyer Snapshot
- Best-fit buyer
- Radiology leadership, pathology leadership, clinical informatics, imaging IT, patient safety, and procurement
- Primary use case
- Triage studies, flag findings, support image interpretation, and coordinate time-sensitive care
- Typical deployment
- Usually integrated with PACS, RIS, worklists, or digital pathology systems and monitored inside the clinical workflow
Evidence questions
- Was the tool tested prospectively and independently on comparable equipment and patients?
- What are sensitivity, specificity, false positive workload, and time-to-action effects?
- How does performance vary by site, scanner, demographic subgroup, and disease prevalence?
Regulatory and workflow questions
- Which FDA authorization covers the exact product version, modality, and intended use?
- Who retains final clinical responsibility and how is disagreement with the AI handled?
- What post-deployment monitoring and material update notification does the vendor provide?
Data and contract questions
- Where are images and derived data processed and retained?
- Which PACS, RIS, pathology, and EHR integrations are supported in production?
- Can data be used for model improvement, and what controls govern secondary use?
Evidence and Regulation
FDA Clearances on Record
Qure.ai appears on 4 cleared products in the federal 510(k) record, across 3 device types.
- AI Triage and Notification Software for Radiology ... 2 cleared products
- AI Lesion Prioritization Software for Radiology ... 1 cleared product
- AI Cancer Detection Software for Radiology ... 1 cleared product
A clearance means the FDA agreed the product is close enough to something already on the market to be sold for that use. It is not a finding that the product helps patients, and it is not a ranking against anything else on this page. A company is linked to an FDA clearance only when the 510(k) applicant name on the government record is confirmed by hand to be that same company, including former corporate names. Name similarity alone is never enough, and rejected matches are listed below with the reason.
What the Published Research Says About This Work
Independent studies on the work itself help separate category evidence from one company's claims.
- AI Stroke Triage ... 24 studies
- AI in Breast Cancer Screening ... 24 studies
- AI in Digital Pathology ... 24 studies