OneMedNet's Real-World Data Powers FDA Clearance of AI-Powered Brain Hemorrhage Detection Software
Key Insights
OneMedNet's regulatory-grade real-world data supported mlHealth 360 (search)'s FDA 510(k) clearance for Scaida BrainCT-ICH (search), an AI software that detects intracranial hemorrhage (search) from CT scans in approximately 5.97 seconds.
The AI-powered solution enables faster clinical triage and supports timely decision-making in acute care settings for stroke (search) and trauma (search) patients.
This milestone validates OneMedNet's position as a leading real-world data provider, with its multimodal clinical datasets enabling successful regulatory submissions for AI medical devices.
OneMedNet Corporation (search) announced that its regulatory-grade real-world data played a critical role in supporting mlHealth 360 (search)'s successful FDA 510(k) clearance for Scaida BrainCT-ICH (search), an AI-powered software solution designed to rapidly detect intracranial hemorrhage (search) from head computed tomography scans. The breakthrough technology can identify suspected intracranial hemorrhage in approximately 5.97 seconds after image acquisition, according to mlHealth 360.
Rapid AI Detection for Critical Care
Scaida BrainCT-ICH (search) leverages artificial intelligence to analyze head CT images and facilitate faster clinical triage in acute care settings, particularly for stroke (search) and trauma (search) patients where time-sensitive diagnosis is crucial. The software's ability to process imaging data in under six seconds represents a significant advancement in emergency medical care capabilities.
OneMedNet's contribution included regulatory-grade real-world data spanning longitudinal electronic medical records, diagnostic imaging, and associated clinical reports. This multimodal dataset enabled mlHealth 360 (search) to develop, validate, and submit their AI model for regulatory approval without compromising data integrity or regulatory compliance.
Strategic Partnership Success
"We are proud to collaborate with our premier partner mlHealth 360 (search) and to support their efforts in advancing patient care through clinically impactful AI," stated Aaron Green, CEO and President of OneMedNet. "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."
Kumar Surender Sinwar, CEO of mlHealth 360 (search), emphasized the partnership's value: "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."
Expanding Data Platform Capabilities
In a separate announcement, OneMedNet revealed it successfully delivered an anonymized real-world data feed representing 1.5 million patients and 4 million encounters to a premier healthcare data and analytics organization. The de-identified dataset exceeded 1.49 billion datapoints of structured and unstructured data, covering extensive longitudinal clinical domains including practitioner notes, immunizations, conditions, medications, encounters, and observations.
This delivery, completed under OneMedNet's subscription model, supported enterprise-scale testing and validation of the recipient's platform, confirming its ability to ingest, harmonize, and operationalize complex, multimodal healthcare data. The milestone represents an important step toward production deployment and commercial scale for the analytics organization.
Market Position and Future Outlook
The FDA clearance of Scaida BrainCT-ICH (search) highlights the growing role of real-world data in enabling next-generation medical AI applications. For OneMedNet, this milestone validates the company's differentiated data platform and expanding role as a trusted data partner for regulated AI and life sciences innovation.
OneMedNet's platform, powered by Palantir AIP Foundry, enables data aggregators, life sciences organizations, and technology partners to reduce integration risk, shorten time-to-market, and scale commercialization of real-world evidence. The company operates across a network of over 2,130 healthcare sites, spanning rare diseases, oncology, cardiology, and other therapeutic areas.
The subscription model delivery demonstrates OneMedNet's ability to provide recurring, on-demand access to continuously refreshed real-world data via standardized schemas and scalable delivery protocols. This approach aims to build durable, high-value partnerships that enhance retention, accelerate monetization, and support long-term shareholder value through predictable annual recurring revenue streams.