Clarius OB AI
Overview
Clarius OB AI is an advanced fetal biometric measurement tool integrated with Clarius’ wireless handheld ultrasound scanners, specifically the Clarius C3 HD3. Leveraging state-of-the-art deep learning models trained on over 30,000 de-identified fetal ultrasound images, this AI solution automates the complex process of fetal biometry measurements. It accurately estimates fetal age, weight, and growth intervals, providing consistent and precise data.
Designed to enhance accessibility to obstetrical prenatal monitoring and care, particularly in resource-limited settings, Clarius OB AI simplifies accurate fetal ultrasound exams for a broader range of healthcare professionals, including midwives and nurses. When activated within the Clarius app during an abdominal scan, the AI automatically highlights key fetal anatomy and places calipers to calculate measurements. These measurements are displayed on-screen and can be seamlessly added to a patient’s electronic record directly from the app.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated fetal biometry measurements
- Estimates fetal age, weight, and growth intervals
- Real-time fetal anatomy identification
- Automated caliper placement
- Integration with Clarius C3 HD3 wireless handheld ultrasound scanner
- User-friendly interface
- Deep learning models trained on over 30,000 de-identified fetal ultrasound images
- Measurements appear on screen and can be added to patient's electronic record from the app
- Included with Clarius membership
- Supports iOS and Android devices
Use Cases
- Prenatal monitoring and care
- Fetal age estimation
- Fetal weight estimation
- Tracking fetal growth intervals
- Empowering midwives and nurses to perform accurate fetal ultrasound exams
- Improving access to obstetrical care in resource-limited areas
What Physicians Need to Know
Clarius OB AI is designed to empower a wider range of clinicians, including midwives and nurses, to perform accurate fetal ultrasound measurements with confidence, especially in areas with limited resources. It serves as an assistive workflow tool to inform clinical management and is not intended to replace clinical decision-making; the clinician retains ultimate responsibility for confirming measurements and exercising clinical judgment. Be aware that the performance of the OB AI model may be suboptimal in cases of multiple gestations, gestational age less than 8 weeks, or when there is a low amount of amniotic fluid. Users should be trained and qualified in ultrasound, and manual adjustment of the automatically placed calipers is possible and encouraged for verification.
Clarius OB AI is integrated into the Clarius App software, which is compatible with both iOS and Android mobile devices. It operates with the Clarius C3 HD3 wireless handheld ultrasound scanner. Fetal measurements and selected ultrasound images can be seamlessly added to a patient's electronic record directly from the app. Access to OB AI is included with a Clarius membership. The app also allows for capturing and documenting photographs alongside ultrasound images for enhanced context.
Details
| Category | OB/GYN AI, Radiology & Imaging AI |
| Pricing |
Subscription-based with scanner purchase
|
| Deployment | Integrated with Clarius handheld wireless ultrasound scanners and accessible via the Clarius App (iOS/Android) and Clarius Cloud. |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Yes AI-estimated Clarius OB AI received U.S. FDA 510(k) clearance (K233955) on June 14, 2024. It is classified as an Ultrasonic Pulsed Doppler Imaging System and is intended to assist in measurements of fetal biometric parameters on ultrasound data acquired by the Clarius Ultrasound Scanner. |
| Integrations | |
| EHR | Not specified |
| Specialties | Maternal-Fetal Medicine, Obstetrics & Gynecology, Radiology |
What the Web Says
Clarius OB AI is an FDA-cleared, AI-powered handheld ultrasound tool designed to simplify fetal biometric measurements and improve access to prenatal monitoring, particularly in resource-limited areas. It automates the placement of calipers for measurements like head circumference, abdominal circumference, femur length, biparietal diameter, and crown rump length, providing estimates of fetal age, weight, and growth intervals. The tool is integrated with the Clarius app, allowing clinicians to add measurements to patient electronic medical records.
Overall: PositiveStrengths
- Automates fetal biometric measurements, reducing the learning curve for new ultrasound users like midwives and nurses.
- Provides consistent and precise measurements for fetal age, weight, and growth intervals.
- Improves access to prenatal monitoring and care, especially in resource-limited areas.
- Offers high-resolution ultrasound images comparable to traditional cart-based systems at a fraction of the cost.
- User-friendly interface with AI-driven image optimization and streamlined workflows.
- Wireless and portable, enhancing ease of use and mobility in various clinical settings.
Limitations
- Some users have reported issues with poor wireless connection, which can slow the frame rate.
- The device can be heavier than some other handheld options.
- Potential for overheating in hot environments.
- The app is not available for MacBook, limiting screen size options for some users.
- Some older Reddit discussions mention concerns about subscription models, though current information indicates OB AI is included with Clarius membership.
Based on reviews from: CNN, BioWorld, TechTarget, AuntMinnie, Axis Imaging News, accessdata.fda.gov, Reddit, YouTube, Physical Therapy Products, The Medical Futurist
Last updated: 2026-07-17
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