OneMedNet Real-World Data Supports FDA 510(k) Clearance of AI-Powered Scaida BrainCT-ICH Software
Rhea-AI Summary
OneMedNet (Nasdaq: ONMD) announced that its regulatory-grade Real-World Data supported mlHealth 360 in obtaining FDA 510(k) clearance for Scaida BrainCT-ICH, an AI software to detect intracranial hemorrhage from head CT scans. OneMedNet supplied multimodal datasets spanning longitudinal EMR, diagnostic imaging, and clinical reports to support model development, validation, and the regulatory submission. Scaida BrainCT-ICH identifies suspected ICH in approximately 5.97 seconds after image acquisition, which the companies say enables faster clinical triage.
This milestone is presented as validation of OneMedNet’s data quality and its role as a trusted partner for regulated AI and life‑sciences submissions.
Positive
- Supported FDA 510(k) clearance of Scaida BrainCT-ICH
- Model detects suspected ICH in ~5.97 seconds after acquisition
- Multimodal RWD supplied: longitudinal EMR, imaging, clinical reports
- Regulatory-grade datasets used for development, validation, submission
Negative
- None.
News Market Reaction – ONMD
On the day this news was published, ONMD gained 12.06%, reflecting a significant positive market reaction. Argus tracked a peak move of +11.2% during that session. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $5M to the company's valuation, bringing the market cap to $49M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
ONMD was down 7.35% while key peers showed mixed moves; notably HCTI appeared in momentum scans with a 72.50000238418579% gain, suggesting ONMD’s weakness was more stock-specific than part of a broad sector trend.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 16 | Large RWD delivery | Positive | +5.9% | Delivery of 1.5M-patient, 4M-encounter RWD feed under subscription model. |
| Dec 22 | Shareholder letter | Positive | +6.9% | CEO highlights liability reduction, Palantir integration, and 37% network growth. |
| Dec 10 | RSNA traction | Positive | -4.8% | Reports strong RSNA engagement and interest in iRWD AI-enabled platform. |
| Nov 24 | Platform showcase | Positive | -1.5% | Plans to showcase redesigned Palantir-based cohort platform at RSNA 2025. |
| Nov 20 | Network expansion | Positive | -10.7% | Announces major iRWD expansion in sites, patients, and clinical exams. |
ONMD news has produced mixed reactions: strong operational and growth updates often face selling pressure, though some data and strategy milestones have triggered short-term gains.
Over the last several months, ONMD has highlighted rapid iRWD network expansion, with provider sites above 2,130 and clinical exams exceeding 186 million. Updates in November 2025 tied growth to a large $60 billion Real-World Evidence market, yet shares sometimes fell on these positives. More recently, a January 1.5 million-patient RWD feed and a 2025 shareholder letter detailing a $19.6 million liability reduction and 37% network growth drew favorable price reactions, framing today’s AI clearance-support news as part of an ongoing RWD commercialization story.
Market Pulse Summary
The stock surged +12.1% in the session following this news. A strong positive reaction aligns with investors rewarding ONMD’s AI-related milestones, as past AI-tagged news produced an average move of 40.23%. The FDA 510(k) clearance supported by ONMD’s Real-World Data reinforces its role in regulated AI workflows. However, prior history shows that even positive operational updates sometimes reversed, and the latest 10-Q highlighted a stockholders’ deficit of -$3.94M and going-concern risk, factors that could temper sustainability.
Key Terms
real-world data technical
intracranial hemorrhage medical
computed tomography medical
electronic medical records medical
510(k) clearance regulatory
AI-generated analysis. Not financial advice.
MINNEAPOLIS, Jan. 22, 2026 (GLOBE NEWSWIRE) -- OneMedNet Corporation (Nasdaq: ONMD), a leading provider of regulatory-grade, AI-ready Real-World Data (RWD), today announced that its high-quality, multimodal clinical data supported mlHealth 360 in obtaining U.S. Food and Drug Administration (FDA) 510(k) clearance for Scaida BrainCT-ICH, an AI-powered software solution designed to facilitate the rapid detection of intracranial hemorrhage (ICH) from head computed tomography (CT) scans.
Scaida BrainCT-ICH leverages artificial intelligence to analyze head CT images and identify suspected intracranial hemorrhage in approximately 5.97 seconds after image acquisition, enabling faster clinical triage and supporting timely decision-making in acute care settings, according to mlHealth 360.
OneMedNet’s regulatory-grade Real-World Data—spanning longitudinal electronic medical records (EMR), diagnostic imaging, and associated clinical reports—played a critical role in supporting model development, validation, and regulatory submission.
This milestone serves as a clear proof point of OneMedNet’s establishment as a leading Real-World Data provider, as an increasing number of life science and AI companies rely on OneMedNet to support FDA submissions. The depth, diversity, and quality of OneMedNet’s curated imaging and clinical datasets enabled mlHealth 360 to access fit-for-purpose data without compromising data integrity or regulatory compliance—reinforcing a strong correlation between high-quality data, successful regulatory outcomes, and sustained demand from new and repeat customers.
Aaron Green, CEO and President of OneMedNet, stated, “We are proud to collaborate with our premier partner mlHealth 360 and to support their efforts in advancing patient care through clinically impactful AI. Seeing OneMedNet’s regulatory-grade Real-World Data—enriched with medical imaging and EMR context—contribute directly to an FDA-cleared solution reinforces the value of high-quality data in accelerating meaningful innovation. This collaboration highlights our mission to responsibly unlock healthcare data and enable partners like mlHealth 360 to deliver better outcomes at scale.”
Kumar Surender Sinwar, CEO of mlHealth 360, added, “We knew early on that partnering with OneMedNet was the right decision. Their ability to provide immediate access to high-quality, regulatory-grade imaging and clinical data meant we could focus on building and validating our AI without worrying about data quality, completeness, or compliance. That confidence was essential in getting Scaida BrainCT-ICH to FDA clearance.”
The FDA clearance of Scaida BrainCT-ICH highlights the growing role of Real-World Data in enabling next-generation medical AI, particularly in time-sensitive clinical applications such as stroke and trauma care. For OneMedNet, this milestone further validates the company’s differentiated data platform and its expanding role as a trusted data partner for regulated AI and life-sciences innovation.
About OneMedNet Corporation
OneMedNet is revolutionizing how the world unlocks Real-World Data (RWD), harnessing the untapped potential of over 2,130 healthcare sites through its iRWD™ platform. This isn’t just data—it’s the lifeblood of innovation, from de-identified medical imaging to electronic health records, fueling breakthroughs for drugmakers, medical device pioneers, and AI visionaries. With a network spanning rare diseases, oncology, cardiology, and beyond, OneMedNet delivers precision insights that redefine patient care and power the next wave of healthcare disruption.
Beyond healthcare OneMedNet’s proprietary AI anonymizes data for industries like finance, retail, and telecom, unlocking endless possibilities—rigorously testing production system upgrades, de-risking complex projects, and securely sharing sensitive data by stripping out personal information. Learn more at www.onemednet.com.
About mlHealth 360
mlHealth 360 is a healthcare AI and analytics company dedicated to transforming the future of medical imaging through secure, HIPAA-compliant, cloud-native solutions. Our advanced platform acts as a force multiplier for radiologists, delivering intelligent case triage, anomaly detection, and automated report generation—reducing diagnostic turnaround times and enhancing clinical decision-making. Designed for seamless integration with existing hospital systems, mlHealth360 offers scalable deployment across both cloud and on-premises environments.
With a growing network of healthcare partners across North America and Asia, mlHealth360 is driven by its core philosophy of Infinite Insight—turning complex medical data into actionable intelligence that empowers clinicians and improves patient outcomes.
Learn more at www.mlhealth360.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements. These statements include, but are not limited to, statements regarding our products, plans and strategies, and our ability to achieve our operational strategies.
Forward-looking statements are based on information available at the time those statements are made and were based on current expectations as well as the beliefs and assumptions of management as of that time with respect to future events. These statements are subject to risks and uncertainties, many of which involve factors or circumstances that are beyond our control. These risks and uncertainties include, but are not limited to: our ability to change the direction of OneMedNet; our ability to keep pace with new technology and changing market needs; the competitive environment of our business; risks inherent with investing in Digital Assets, including Digital Asset’s volatility; our ability to implement our Digital Asset treasury strategy and its effects on our business; and the other risks described in our most recent Annual Report on Form 10-K and our subsequent filings with the Securities and Exchange Commission. Except as required by law, we do not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments, or otherwise.
OneMedNet Contacts:
Michael Wong, VP Marketing
Email: michael.wong@onemednet.com
SOURCE: ONEMEDNET CORPORATION
FAQ
What did OneMedNet announce about FDA clearance for Scaida BrainCT-ICH (ONMD)?
How fast does Scaida BrainCT-ICH identify suspected intracranial hemorrhage?
What types of data did OneMedNet provide to support the clearance?
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Which company received the FDA 510(k) clearance for Scaida BrainCT-ICH?
