Samsung Medison completed its acquisition of French ultrasound-AI company Sonio on August 30, 2024. Announced that May, the deal gave Samsung Medison a specialist in AI-assisted prenatal ultrasound, image-quality checks and clinical workflow—not a general-purpose medical-diagnostics company. Sonio’s software is intended to assist clinicians, and the company said it would continue operating independently with products compatible with ultrasound systems from multiple manufacturers.
What Samsung Medison bought
The buyer was Samsung Medison, Samsung Electronics’ medical-device affiliate focused on diagnostic imaging. The target, Sonio SAS, is a French medical-technology company founded in 2020 and focused on obstetric and gynecological ultrasound. The agreement covered 100% of Sonio’s shares. Samsung said Sonio would remain an independent company headquartered in France.
Samsung announced the agreement on May 8, 2024, subject to regulatory approval. The acquisition closed on August 30, 2024, after approval from the French government for the foreign investment. Samsung and Sonio announced the completed transaction publicly in early September. Samsung’s May 2024 announcement and its completion announcement describe the agreement and closing.
Contemporary reporting put the transaction at about 126 billion South Korean won, or roughly $92 million. Samsung’s announcement did not disclose a purchase price, so that figure should be treated as a reported estimate, not a price confirmed by Samsung. TechTimes reported the figure when the deal was announced.
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What Sonio’s products do
Sonio sells software for prenatal ultrasound examinations. Its products address image acquisition and review, examination workflow and reporting. Their role is to support clinical work; they are not a substitute for a clinician’s interpretation or care decisions.
Sonio Detect: image and view assistance
Sonio Detect uses AI to identify supported fetal-ultrasound views and anatomical structures, check whether supported views meet specified image-quality criteria, and provide feedback during examinations. Its intended use is to help clinicians acquire and assess images more consistently. The product does not amount to an automated conclusion about whether a fetus has a particular condition.
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- [ Non-invasive fetoscope ] - Skywin Fetoscope for Baby Heartbeat Detection is a non-invasive way to listen to a baby's heartbeat. Detection is barely as early as 24-30 weeks, but the best chance should be around 30 - 36 weeks to hear the faint tones. Normally undetectable from 0 - 24 weeks. It takes time and practice to locate your baby's heartbeat and correctly position yourself and the fetoscope to hear the heartbeat. Please be patient as you may have better luck finding it in later weeks, it might be helpful to refer to the 'How to Use' instructions on the box
- [ Instruction How to Use (1st Step) ] -To use the Pinard horn for fetal heart monitoring, find a quiet, comfy spot. Insert earpieces tightly, and minimize airflow. Listen to different belly areas, especially below the belly button during the 2nd trimester. Place the horn where the baby's heart is, and add slight pressure for a clear sound. Count heartbeats (120-160 bpm).
- [ Instruction How to Use (2nd Step) ] - If no heartbeat is heard, DO NOT GIVE UP! Babies tend to move, so try again later. Remember, Detecting very young fetuses is harder; fetoscopes typically aren't strong enough to hear anything until 30-36 weeks gestation, about halfway through the second trimester. (Please check DESCRIPTION below for a detailed instruction)
- [ A Special Notes ] - Remember, a fetoscope is designed to listen to fetal heart tones, so if you're testing it on your heartbeat or another adult's heartbeat it's not going to sound very loud and clear either. It is designed to auscultate fetal heart tones.
- [ Portability Is The Key ] - The compact and portable design of the Skywin Fetoscope for Baby Heartbeat Detection makes it convenient for parents to carry and use wherever they are, allowing them to share precious moments with loved ones who need to worry about replacing batteries or recharging it
The original FDA record for Sonio Detect is 510(k) K240406, with a decision date of April 26, 2024. The FDA describes the device’s functions and intended use in its 510(k) database entry. That clearance predated Samsung’s May acquisition announcement.
Sonio Pro: examination workflow and reporting
Sonio describes Sonio Pro as a cloud-based software-as-a-service product for OB/GYN examinations. Its listed capabilities include transmitting ultrasound media in DICOM format, managing worklists, supporting HL7 interoperability with systems such as electronic medical records and billing platforms, and reviewing images with basic medical-image processing functions. The exact features available to a clinic depend on its product configuration and integrations. Sonio’s product descriptions cover both Detect and Pro.
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Why the acquisition fits Samsung Medison
Samsung Medison makes ultrasound equipment; Sonio contributes software, AI and reporting expertise tailored to prenatal examinations. Samsung said it intended to combine those capabilities to expand AI-enabled medical devices, improve prenatal-ultrasound workflows and strengthen its presence in women’s health, maternal-fetal medicine and fetal therapy. It also cited the potential to support care in underserved settings and amid healthcare workforce shortages. Those are strategic aims, not evidence by themselves of improved patient outcomes.
The U.S. healthcare announcement placed Sonio alongside Samsung’s SonoSync tele-sonography solution and S-Hub ultrasound-management tool, pointing to a wider software ecosystem around ultrasound as well as a hardware-and-software combination. The commercial value will depend on practical factors such as integration with clinic systems, clinician adoption and the ability to deploy the tools in different care settings.
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- [ Non-invasive fetoscope ] - Skywin Fetoscope for Baby Heartbeat Detection is a non-invasive way to listen to a baby's heartbeat. Detection is barely as early as 24-30 weeks, but the best chance should be around 30 - 36 weeks to hear the faint tones. Normally undetectable from 0 - 24 weeks. It takes time and practice to locate the heartbeat of your baby and correctly position yourself and the fetoscope to be able to hear the heartbeat. Please be patient as you may have better luck finding it in later weeks, it might be helpful to refer to the 'How to Use' instructions on the box
- [ Instruction How to Use (1st Step) ] -To use the Pinard horn for fetal heart monitoring, find a quiet, comfy spot. Insert earpieces tightly, and minimize airflow. Listen to different belly areas, especially below the belly button during the 2nd trimester. Place the horn where the baby's heart is, and add slight pressure for a clear sound. Count heartbeats (120-160 bpm).
- [ Instruction How to Use (2nd Step) ] - If no heartbeat is heard, DO NOT GIVE UP! Babies tend to move, so try again later. Remember, Detecting very young fetuses is harder; fetoscopes typically aren't strong enough to hear anything until 30-36 weeks gestation, which is about halfway through the second trimester. (Please check DESCRIPTION below for a detailed instruction)
- [ A Special Notes ] - Remember, a fetoscope is designed to listen to fetal heart tones, so if you're testing it on your heartbeat or another adult's heartbeat it's not going to sound very loud and clear either. It is designed to auscultate fetal heart tones.
- [ Portability Is The Key ] - The compact and portable design of the Skywin Fetoscope for Baby Heartbeat Detection makes it convenient for parents to carry and use wherever they are, allowing them to share precious moments with loved ones who need to worry about replacing batteries or recharging it
Compatibility is broader than Samsung hardware, but not universal
Samsung said Sonio’s products and services would remain compatible with ultrasound equipment from multiple manufacturers. FDA documentation for the cleared Sonio Detect version identifies systems from GE Medical, Samsung and Canon, with Philips compatibility depending on the version. This is not a promise of plug-and-play support for every machine: the supported device, software version and configuration matter. The FDA clearance documentation describes compatibility for the K240406 device.
That vendor-neutral position could let Sonio serve clinics with mixed ultrasound fleets while giving Samsung access to software that is not necessarily tied to its own machines. Whether a specific clinic can use a particular combination still requires confirmation of technical support and regulatory status.
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What FDA clearance does—and does not—establish
A 510(k) clearance means the FDA found the submitted device substantially equivalent to a legally marketed predicate device for the intended use described in the submission. It is not a blanket endorsement of every feature or future version, and it does not establish that the system can diagnose every fetal abnormality, choose treatment, or replace professional judgment.
- View and anatomy recognition: the software can identify supported views and structures, but recognition is not the same task as diagnosing a condition.
- Image-quality checks: feedback can help assess whether supported images meet specified criteria; it does not guarantee a complete or clinically correct examination.
- Clinical decisions: qualified clinicians remain responsible for interpreting findings and deciding what care is appropriate.
- Performance in practice: results can depend on image quality, acquisition technique, patient factors, supported views and workflow. Automated results may be wrong and need clinical review.
Samsung’s completion announcement cited sensitivity above 90% for recognizing fetal ultrasound views. That is a company-reported figure for view recognition, not a measure of accuracy in diagnosing fetal conditions. Neither this figure nor the clearance alone demonstrates improved downstream outcomes.
Regulatory milestones also apply to particular products and markets. Sonio announced a CE mark for Sonio Detect in France in September 2024, and later announced that a third version received FDA 510(k) clearance on March 25, 2026. These updates do not mean that every version is authorized or commercially available everywhere. Sonio’s news archive reports the later announcement, while the FDA documentation for the later version provides its clearance record.
What clinics should consider
For a healthcare provider, the acquisition matters if Sonio’s tools fit the clinic’s imaging and reporting needs. Potential value lies in assistance with standardized image acquisition, review and documentation; it should not be assumed that workflow software will improve every diagnostic or patient outcome.
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- Assess IT and data governance: DICOM, HL7, cloud services and electronic-record integrations can require security, privacy, data-residency and connectivity review, along with hospital IT approval.
- Evaluate the clinical workflow: determine how staff review AI feedback, handle errors, document findings and maintain clinical oversight.
- Confirm local requirements: FDA clearance, CE marking and French investment approval are distinct events; none alone establishes availability, reimbursement or procurement approval in every market.
What the deal means now
The acquisition is complete, and Sonio has continued to announce product development after joining Samsung Medison. The lasting strategic point is the combination of Samsung’s ultrasound business with software aimed at prenatal imaging and examination workflow. It expands a specialized women’s-health offering; it is not evidence that Samsung has acquired a general-purpose AI diagnostic system or that ultrasound examinations can be conducted without clinical expertise.
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