Company and Stock Identity

How Sonio Connects to the Public Market

Company structure
Samsung fetal ultrasound software business
Market access
Public parent: Samsung. The exact listed Samsung entity holding the shares was not verified, so no ticker is recorded here.
Research focus
Samsung Medison also makes ultrasound machines, so ask whether Sonio's software is still sold for other makers' scanners or is drifting toward Samsung equipment only. The June 2026 clearance covers a version embedded inside an ultrasound machine, which is the one that decides that question. Check each clearance separately: reporting, view detection and abnormal-finding detection are different permissions.

Sonio announced on 2 September 2024 that the French Ministry of the Economy and Finance approved the acquisition of 100 percent of its shares by Samsung, and its own site now carries the line that Sonio is a Samsung company, with Samsung Medison named alongside it. Which Samsung entity holds the shares was not confirmed on the pages read on 2026-10-10.

A current price is not available in the automated United States market snapshot. Use the named exchange or the company investor-relations page for current trading data.

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First-Hand Company News

Latest Developments

... Sonio ... Company source

Sonio gets FDA clearance to put its fetal scan AI inside the ultrasound machine

Sonio said on 24 June 2026 that the FDA cleared the Sonio Suspect Integration Configuration under K261519, a version of its abnormal fetal finding detection that can be built into an ultrasound machine instead of running only as a standalone web application. The company says it keeps working where computing power is limited, calls it the first AI cleared as an integration module in an ultrasound machine for anomaly detection, and describes it as its fifth FDA clearance in under three years.

Why it matters: Running inside the scanner removes the second screen and the network dependency, which is the part that usually kills imaging AI in a busy clinic or a site with thin bandwidth. It also makes the software something a machine maker can ship, and Samsung owns Sonio, so a buyer should ask which scanners the module will actually reach. The clearance covers this configuration, not a new claim about how well the detection works, so the performance question is still the earlier evidence.

... Sonio ... Company source

Sonio gets FDA clearance for a third version of its fetal view checker

Sonio said on 25 March 2026 that the third version of Sonio Detect received FDA 510(k) clearance for automatically detecting ultrasound views and anatomical structures and for checking image quality in prenatal exams. The company reports that it detects 14 first trimester views at 88.6 percent sensitivity and 98.1 percent specificity, and 40 second and third trimester views at 90.1 percent sensitivity and 99.3 percent specificity, covering up to 65 percent of the ISUOG and AIUM detailed exam protocols and identifying 58 anatomical structures. The announcement does not give a K number.

Why it matters: Checking that the exam was complete is a quieter job than finding a defect, and it is often the one that saves a clinic money, because an incomplete scan means calling the patient back. Covering 65 percent of a protocol also means a third of it is still on the sonographer, so this is a checklist helper rather than a replacement. The sensitivity and specificity figures are the company's own, and view detection accuracy says nothing about how well the separate abnormal-finding product performs.

See company developments across the healthcare AI market.

Careers and Qualifications

What to Know Before Applying

Work areas: Sonio keeps its openings on an outside job board rather than on its own site, so the listings are only visible there.

Qualification signal: The product runs during a live scan and then writes a report, so people who understand both sonographer workflow and clinical reporting rules count more than general model builders. Fetal medicine experience is the scarce part.

Check current roles at Sonio. 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

Training to Compare

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

Sonio appears on 2 cleared products in the federal 510(k) record, across 1 device type.

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.

First-Hand Sources