BioticsAI

by BioticsAI, Inc.  · Based in United States → — AI Powered Fetal Ultrasound Screenings
Maternal-Fetal Medicine Obstetrics & Gynecology Radiology
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Hybrid pricing model with a subscription-based charge.
Regulatory Status Disclosed

Overview

BioticsAI is an AI-powered software designed to enhance prenatal ultrasound screenings. It provides a clinical intelligence platform that validates the quality and completeness of fetal anomaly screenings, pinpoints fetal vulnerabilities, and automates the generation of reports. The tool empowers obstetricians, sonographers, and prenatal care providers by accurately identifying errors in fetal ultrasound screenings, localizing problematic anatomical views, detecting fetal anomalies, and providing real-time feedback to clinicians. By integrating seamlessly into existing workflows, BioticsAI aims to improve efficiency, productivity, and diagnostic precision while reducing administrative overhead, allowing healthcare professionals to focus on patient care. It is built to facilitate meeting AIUM & ISUOG quality guidelines and offers unparalleled integration capabilities with EHR, PACS, and HIS systems.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-Driven Fetal Ultrasound (Real-Time Plane Capture)
  • Imaging Quality Assessment
  • Anatomical Structure Evaluation
  • Automated Reporting and Documentation
  • Fetal Anomaly Detection
  • Real-time Feedback to Clinicians
  • EHR, PACS, and HIS System Integration
  • Reduction of Diagnostic Errors
  • Standardized Image Acquisition
  • Second-Opinion Layer for Ultrasounds

Use Cases

  • Improving diagnostic precision in prenatal care
  • Enhancing practice efficiency for obstetricians and prenatal care providers
  • Reducing administrative overhead for medical professionals
  • Ensuring comprehensive and patient-centric care for expectant mothers
  • Addressing maternal-health disparities through consistent diagnostic quality
  • Facilitating adherence to AIUM & ISUOG quality guidelines

What Physicians Need to Know

Fetal Monitoring AI
BioticsAI is an FDA-cleared AI-powered software that validates the completeness and quality of fetal anomaly screenings, localizes fetal vulnerabilities, and automates report generation. It provides real-time feedback to clinicians during ultrasound examinations to detect fetal abnormalities and pregnancy issues, aiming to standardize detection accuracy.
Ultrasound Image Analysis
This is a core function, with BioticsAI developing models to identify errors in fetal ultrasound screenings, localize problematic anatomical views, and identify fetal anomalies. It performs real-time quality assessment of images, automated detection of anatomical landmarks for completeness, and standardizes image acquisition. The system automatically annotates ultrasound images with fetal anatomical planes and structures, covering nearly 70 anatomical regions and adhering to AIUM & ISUOG quality guidelines.
Pregnancy Risk Assessment
While not a standalone feature, the system's ability to detect fetal anomalies and provide comprehensive screenings contributes to early risk identification. Future plans include modules for placental health assessment, fetal growth tracking, and maternal-fetal risk scoring.
Maternal Health Monitoring
The primary focus is fetal health through ultrasound, but BioticsAI's broader vision includes expanding into reproductive health and postnatal maternal care, with the aim of reducing maternal-health disparities.
Cervical Screening AI
This is not a current offering of BioticsAI; its focus is on fetal ultrasound. However, the company has a long-term vision to expand into gynecology.
Prenatal Testing Integration
BioticsAI is designed to integrate seamlessly into existing clinical workflows, including hospital PACS and EMR systems. It automates report filing and follow-up scheduling.
Postpartum Care Tools
While the long-term vision includes 'postnatal maternal care,' specific postpartum care tools are not currently detailed in the available information.
Physician Tip

BioticsAI improves efficiency and productivity by reducing administrative overhead and automating report generation, saving significant time per patient. It provides real-time feedback and a 'second opinion' during ultrasound scans, enhancing diagnostic accuracy and the completeness of screenings, which can increase from 70% to 90%. The system helps standardize image acquisition and reduces the need for repeat scans, thereby lowering costs and patient anxiety. It integrates seamlessly into existing workflows and is designed for quick onboarding, allowing obstetricians to leverage the tool effectively within a day.

BioticsAI is a cloud-based Software as a Service (SaaS) solution that integrates seamlessly with existing clinical workflows. It is designed to plug into any ultrasound machine and supports integration with hospital PACS and EMR systems. The system utilizes a standard DIMSE connection for integration within the clinic's network. Its development adheres to the quality guidelines set by the International Society for Ultrasound in Obstetrics and Gynecology (ISUOG) and the American Institute of Ultrasound in Medicine (AIUM).

Details

Category OB/GYN AI, Radiology & Imaging AI
Pricing Hybrid pricing model with a subscription-based charge. — Subscription-based; hybrid model
DeploymentCloud-based (SaaS)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

BioticsAI received FDA 510(k) clearance (K250959) on January 19, 2026, as a Class II medical device. It is cleared for clinical use in prenatal ultrasound quality and anatomical completeness assessment, analyzing fetal ultrasound images to automatically detect views and anatomical structures, and facilitating quality criteria verification as a concurrent reading aid for healthcare professionals.
Integrations
EHR Not specified
Specialties Maternal-Fetal Medicine, Obstetrics & Gynecology, Radiology

What the Web Says

BioticsAI is an AI-powered software designed to improve the accuracy and efficiency of prenatal ultrasound screenings by validating image quality, identifying fetal vulnerabilities, and automating report generation. It aims to address the high rate of misdiagnosis in fetal malformation cases, which can be as high as 50%, often due to operator-dependent errors during ultrasound examinations. The platform provides real-time feedback to clinicians, helping them ensure completeness of scans and offering a secondary opinion to overworked OB/GYNs and sonographers. BioticsAI received FDA clearance in January 2026 and won TechCrunch Disrupt's Startup Battlefield in 2023.

Overall: Positive

Strengths

  • Improves diagnostic accuracy in prenatal ultrasounds, with an algorithm boasting 98% accuracy.
  • Enhances workflow efficiency for clinicians and saves approximately 8 minutes per patient on documentation time.
  • Reduces operator-dependent errors in ultrasound exams and increases the completeness of scans from 70% to 90%.
  • Provides real-time feedback to clinicians, localizing problematic anatomical views and automatically generating high-quality documentation.
  • Integrates seamlessly with existing ultrasound machines and can be used as a vendor-agnostic solution.
  • Addresses the global shortage of obstetrics professionals by streamlining administrative tasks, allowing doctors to focus on patient care.

Limitations

  • Limited funding compared to competitors, raising questions about scaling production, marketing, and sales.
  • Faces challenges in widespread adoption due to complex hospital purchasing processes and unclear reimbursement for AI medical software.
  • Operates in a crowded market with established competitors.
  • Early development faced challenges with desktop annotation applications lacking transparency and review capabilities.
  • Experienced uptime issues and high latency with their open-source annotation solution during development.
  • The process of building proprietary datasets for training models is extensive and requires high-quality, accurately labeled ultrasound imagery.

Based on reviews from: AI for the Betterment of Humanity: Spotlight on BioticsAI and the Future of Obstetrics, BioticsAI Boasts High Diagnostic Accuracy in Prenatal Ultrasounds - YouTube, BioticsAI Scales Lifesaving AI with Label Studio - HumanSignal, AI-powered ultrasound: BioticsAI is tackling misdiagnosis of unborn babies | Startmate, December 22, 2025 BioticsAI, Inc. Mary Vater Director of Regulatory Affairs Innolitics LLC 1101 West 34th St. #550 Austin, T - accessdata.fda.gov, BioticsAI's AI Ultrasound Gets FDA Nod But Faces Market Challenges | Whalesbook, Navigating FDA Approvals and Fundraising: Insights from BioticsAI's CEO : r/kainjoo, FDA Clears BioticsAI's AI-Powered Fetal Ultrasound System : r/ai_news_byte_sized - Reddit, Tested 5 AI scientist platforms for biotech research - here's what I found : r/AI_Agents, Biotics AI - YouTube, BioticsAI Pitches at Startup Battlefield | TechCrunch Disrupt 2023 - YouTube, BioticsAI Secures FDA Approval for AI-Powered Fetal Ultrasound After 2023 Disrupt Battlefield Win - Cyprus Business Group, ElevenLabs Reviews on G2: 4.6 from 30 users, Keeping Your Team Motivated When FDA Approval Isn't Guaranteed l Build Mode, The AI hype in biotech: Well warranted, bullshit, or a bit of both? Curious as to this subs thoughts - Reddit, Does Capterra have legit reviewers? - Quora, Are G2 reviews reliable? - Quora, Capterra Reviews 2026: Details, Pricing, & Features | G2, We Tested G2 AI Reviews - Don't Recommend: Here's Why - Blastra, Capterra Pros and Cons | User Likes & Dislikes - G2, Is capterra good? - Quora, G2 Reviews | Read Customer Service Reviews of www.g2.com - Trustpilot

Last updated: 2026-07-18

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Press & Coverage

Cyprus Business Group
BioticsAI Secures FDA Approval for AI-Powered Fetal Ultrasound After 2023 Disrupt Battlefield Win
BioticsAI, winner of TechCrunch Disrupt Battlefield 2023, received U.S. FDA clearance for its AI software to detect fetal abnormalities via ultrasound, marking a significant step towards clinical deployment.
2026-01
TechCrunch
TechCrunch: BioticsAI, gains FDA clearance for its AI-powered fetal ultrasound product
BioticsAI secured FDA 510(k) clearance for its AI-driven fetal anatomy tool, making it the first US-founded company to achieve this for routine midtrimester fetal ultrasound examinations.
2026-01
Reddit
FDA Clears BioticsAI's AI-Powered Fetal Ultrasound System : r/ai_news_byte_sized
BioticsAI's Battlefield 2023 system gained FDA approval for AI-assisted fetal ultrasound analysis, aiming to standardize detection accuracy across various clinicians and imaging environments.
2026-01
AI NEWS
AI Protects the First Life: BioticsAI Receives FDA Approval to Accurately Address Fetal Misdiagnosis Challenges
BioticsAI, the 2023 TechCrunch Disrupt winner, announced FDA approval for its AI software that helps doctors detect fetal abnormalities in ultrasound images, significantly improving prenatal screening accuracy.
2026-01
FindArticles
BioticsAI Wins FDA Clearance For Fetal Ultrasound AI
BioticsAI received U.S. FDA clearance for its AI software assisting clinicians in fetal ultrasound exams, aiming to reduce missed views, standardize measurements, and flag concerns in real-time.
2026-01
daily.dev
Biotics AI, Battlefield 2023, gains FDA approval for its... - daily.dev
BioticsAI received FDA clearance for its computer vision AI software designed to detect fetal abnormalities in ultrasound images, supporting quality assessment, automated reporting, and clinical workflow integration.
2026-01
accessdata.fda.gov
BioticsAI, Inc. Mary Vater Director of Regulatory Affairs Innolitics LLC
The FDA's 510(k) premarket notification acknowledges BioticsAI as a software used by OB/GYN care centers for prenatal ultrasound review and reporting, utilizing AI to automatically annotate images and facilitate report generation.
2025-12
YouTube (StartUp Health)
BioticsAI Boasts High Diagnostic Accuracy in Prenatal Ultrasounds
BioticsAI, a TechCrunch Disrupt 2023 winner, presented its AI platform at HLTH 2024, highlighting its 98% diagnostic accuracy in detecting fetal abnormalities and improving ultrasound completeness from 70% to 90%.
2024-12

Videos

Product demos, reviews, and walkthroughs for BioticsAI.

View all on YouTube

Frequently Asked Questions

BioticsAI is designed as a software-as-a-service (SaaS) solution that seamlessly integrates into existing clinical workflows, particularly with post-processing ultrasound solutions and reporting systems like Viewpoint 6. It functions as a concurrent reading aid during and after fetal anatomical ultrasound examinations, automating report generation and documentation to save clinicians time.
BioticsAI provides real-time quality assessment and anatomical integrity checks during ultrasound scans, helps localize fetal anomalies, and automates report generation. This technology aims to improve early detection of fetal abnormalities, standardize ultrasound quality across diverse care settings, and reduce the high misdiagnosis rates associated with fetal malformation.
While the search results indicate that BioticsAI is built with compliance in mind, including HIPAA, specific details on its data privacy measures beyond general compliance modules are not extensively detailed. Generally, HIPAA compliance for AI solutions requires strict access management, data encryption, de-identification of data for research, updated policies, and a Business Associate Agreement (BAA) with vendors.
BioticsAI has received FDA clearance for its AI-powered fetal ultrasound product, making it the first regulatory approval for an artificial intelligence-driven prenatal imaging solution in the United States. It was cleared under the De Novo pathway as a Class II medical device.
BioticsAI utilizes a volume-based pricing model for API calls to its algorithms, aiming to incentivize hospitals through demonstrated return on investment (ROI). This ROI is achieved by saving time, increasing patient volume, reducing repeat scans, and potentially mitigating costs related to medical malpractice.
While BioticsAI aims to improve accuracy, potential risks in healthcare AI generally include concerns about algorithmic robustness, the need for high-quality, diverse training data to avoid biases, and the evolving legal frameworks around AI liability. Physicians also express concerns about over-reliance on AI tools and the potential for devaluing human expertise.
No, BioticsAI is positioned as an 'AI co-pilot' and an assistive tool rather than a replacement for skilled healthcare professionals. It helps sonographers and obstetricians by validating screening completeness, localizing vulnerabilities, and automating documentation, thereby enhancing their ability to provide high-quality care and make informed decisions.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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