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Philips gains FDA 510(k) clearance for cloud-based Cardiovascular Workspace to accelerate AI in U.S. cardiology

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Philips gains FDA 510(k) clearance for cloud-based Cardiovascular Workspace to accelerate AI in U.S. cardiology

SHERIDAN, WYOMING - November 25, 2025 - Philips has received U.S. FDA 510(k) clearance for the latest release of its Cardiovascular Workspace (IntelliSpace Cardiovascular, ISCV), enabling U.S. health systems to deploy the cardiovascular imaging and information management platform as a cloud-hosted, SaaS solution on Philips HealthSuite. The move positions hospitals and cardiology networks to modernize IT, scale integrated diagnostics, and accelerate real-world adoption of AI-enabled cardiovascular workflows.

Cloud-based cardiovascular informatics for U.S. health systems

The newly cleared Cardiovascular Workspace on HealthSuite reflects a broader shift among healthcare organizations toward cloud infrastructure to streamline IT operations and reduce total cost of ownership. By moving cardiovascular reading and reporting into a SaaS model, providers can standardize deployments across sites, reduce on-premises hardware footprints, and simplify upgrades.

Cloud hosting also supports secure, anywhere access to patient data and imaging, giving cardiologists and multi-disciplinary teams greater flexibility in how and where they read studies. With Philips Cardiovascular Workspace on HealthSuite, clinicians gain secure, anytime and anywhere access to patient data and imaging, for improved speed, precision, and reproducibility in cardiovascular reading and reporting.

Foundation for AI-enabled cardiology workflows

The FDA clearance explicitly sets the stage for broader AI integration into cardiovascular care pathways. As health systems consolidate imaging and reporting in the cloud, they can more easily introduce AI algorithms for measurements, decision support, and workflow automation across large, heterogeneous datasets.

"Our cloud-enabled Cardiovascular Workspace provides the foundation for future AI enabled tools and workflow insights across the cardiology care continuum," said Madhuri Sebastian, Business Leader Imaging Informatics at Philips. "With cloud deployment, we are enabling secure remote reading and improving efficiency. Our approach is a true differentiator because it unlocks the ability to scale and innovate through large datasets. This is how Philips is helping health systems deliver smarter, more connected cardiovascular care."

As Tom C. Nguyen, M.D., FACS, FACC, chief medical executive and Barry T. Katzen Endowed Chair of Baptist Health Miami Cardiac & Vascular Institute shared, "[Health systems are] accelerating AI integration in clinical workflows, focusing on automated imaging analysis, predictive risk modeling and workflow optimization to drive more precise, efficient and proactive cardiovascular care. While the present use of AI in heart care often focuses on operational improvements, the future promises deeper, more meaningful impacts on patient diagnosis and treatment." [2]

Scaling integrated diagnostics with AWS and HealthSuite

Philips Cardiovascular Workspace on HealthSuite extends the company's integrated diagnostics portfolio by bringing cardiovascular services into the same cloud-based model that underpins Philips PACS HealthSuite. For customers, this means they can align radiology and cardiology imaging workflows on a single, scalable cloud platform while leveraging shared data and governance models.

The release also deepens Philips' collaboration with Amazon Web Services (AWS) as a strategic cloud partner. "In cardiovascular care especially, the ability to scale innovation depends on unlocking the power of data through secure, cloud-enabled solutions across the entire care continuum," said Dr. Rowland Illing, Chief Medical Officer and Director, Healthcare and Life Sciences at Amazon Web Services. "Philips is building the kind of integrated data ecosystem that empowers clinicians with actionable insights and delivers measurable impact for patients."

Operational impact for hospitals and cardiology networks

For CIOs, CMIOs and cardiology service line leaders, the combination of FDA 510(k) clearance and cloud-hosted deployment translates into tangible operational benefits. A SaaS-based cardiovascular informatics environment can help:

  • Reduce infrastructure and maintenance burdens on hospital IT teams
  • Enable secure remote reading to support 24/7 coverage and sub-specialist collaboration
  • Standardize workflows and reporting templates across multi-site health systems
  • Provide a future-ready platform to plug in AI tools as they receive regulatory clearance

By unifying cardiovascular imaging and information management in the cloud, health systems can build more connected, data-rich cardiology pathways while maintaining compliance with U.S. regulatory and security requirements.

Showcasing connected cardiology at RSNA 2025

Philips will spotlight Cardiovascular Workspace on HealthSuite within a broader integrated diagnostics line-up at the Radiological Society of North America (RSNA) Annual Meeting, taking place November 30-December 3, 2025, in Chicago, USA. The company plans to feature the solution and related offerings in the Philips booth (#6730), providing radiology and cardiology leaders with an opportunity to evaluate how cloud-based diagnostics and AI could fit into their own modernization roadmaps.

As U.S. providers refine their digital health and AI strategies, the combination of FDA-cleared software, scalable cloud architecture, and an expanding ecosystem of AI tools positions Philips' Cardiovascular Workspace as a key building block in intelligent, connected cardiovascular care.

For full product information and specifications, visit https://www.usa.philips.com/healthcare/product/HCNOCTN198/cardiovascular-workspace.

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