OneMedNet Supports mlHealth 360 in Obtaining FDA 510(k) Clearance
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 22 2026
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Should l Buy ONMD?
OneMedNet announced that its clinical data supported mlHealth 360 in obtaining U.S. Food and Drug Administration, FDA, 510(k) clearance for Scaida BrainCT-ICH. 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."
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Analyst Views on ONMD
About ONMD
OneMedNet Corporation is a global provider of clinical imaging innovation and curator of regulatory-grade Imaging Real World Data (RWD), through its OneMedNet iRWD solution. The Company provides solutions within the clinical image archives of healthcare providers. It de-identifies, searches, and curates a data archive locally, bringing a wealth of internal and third-party research opportunities to providers. By leveraging this extensive federated provider network, together with technology and in-house clinical expertise, the Company meets the rigorous RWD life science requirements. OneMedNet iRWD offers advanced technology, clinical expert curation, and service. Medical imaging and associated clinical data are indexed at each network site using artificial intelligence (AI)/ machine learning (ML) technology. This includes EHR, radiology, cardiology, lab, path, and others. In addition to its customized data packages, it also offers regulatory-grade, pre-packaged imaging RWD sets.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Technological Innovation: VentriPoint Diagnostics is transforming standard 2D ultrasound images into MRI-level 3D heart models, significantly reducing costs and complexity, which is expected to drive rapid growth in its subscription business.
- Surge in Investment Demand: The company recently doubled its private placement from $500,000 to $1 million, with funds allocated for commercialization and market expansion, showcasing strong investor confidence in its technology and market potential.
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See More
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- AI-Driven Search Capabilities: The new platform features AI-driven natural language search for complex discovery tasks, providing real-time availability and longitudinal insights. This advancement allows clients to assess cohort feasibility faster, addressing market demands for rapid response.
- Recurring Revenue Growth: The platform's tight integration with subscription workflows supports OneMedNet's recurring revenue growth strategy. CEO Aaron Green emphasized that this transformation meets market needs, enabling clients to determine cohort feasibility in minutes, thereby enhancing the company's competitive edge.
See More
