DEEPVESSEL FFR
AI-enabled, non-invasive CT fractional flow reserve analysis for coronary artery disease
Company profile
Company profile
Keya Medical is a medical artificial intelligence company specializing in deep learning solutions for cardiovascular imaging and diagnostics. Founded in 2016 as CuraCloud in Seattle, the company initially focused on AI algorithms for medical imaging and bioinformatics, achieving early success with FDA-cleared software for triaging intracranial hemorrhage from head CT scans. In 2020, the company rebranded as Keya Medical and expanded its focus to AI-driven cardiovascular imaging. Headquartered in Seattle, Washington, and Shenzhen, China, Keya Medical operates across Asia, Europe, and North America. The company's primary offering is DEEPVESSEL FFR, an AI-enabled, non-invasive CT fractional flow reserve (FFR-CT) analysis tool that provides physiological functional assessment of coronary arteries using coronary computed tomography angiograms. This technology helps clinicians reduce unnecessary invasive testing, improve patient safety, and lower cardiovascular testing costs. DEEPVESSEL FFR has achieved regulatory clearance in multiple markets: CE-marked in 2018, NMPA-approved in China in 2020, FDA-cleared in 2022, and HSA-certified in Singapore in 2023. The company also offers DEEPVESSEL Plaque for quantitative plaque analysis, currently available for research use only in the United States. Keya Medical's solutions are designed to support confident clinical decision-making from a single CCTA examination, combining advanced deep learning technology with streamlined workflow integration. The company has been featured at major international cardiovascular and imaging conferences including SCCT, ECR, and RSNA.
Company description KeyaMed NA official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Cloud Saas deployment with recorded integration context.
Company milestones
FDA clearance in 2022, HSA certification in Singapore in 2023, new Category I CPT code 75580 implementation January 2024, expansion of U.S. commercial team with regional sales directors
Partnerships
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
AI-enabled, non-invasive CT fractional flow reserve analysis for coronary artery disease
AI-driven coronary plaque analysis platform for CCTA workflow
03 · Research intelligence
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Research
No linked records are currently available.
Clinical validation
No linked records are currently available.
Regulatory
K213657 · 510k · Apr 1, 2022
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Using CT-derived FFR to avoid invasive catheterization
Non-invasive assessment of coronary artery disease
Reducing need for invasive procedures
Implementation of AI-based CT-FFR in outpatient imaging centers for functional assessment alongside coronary CT angiography
Transforming clinical practice with FFRCT and DVFFR for superior patient care and better outcomes
Transformed practice allowing superior patient care and better outcomes
05 · Leadership
Leadership profiles and professional links from the current Company record.
Mary-Pierre Waiss
President, North America
Matt Dichard
Sales Director, Northeast Region
Tom Murphy
Sales Director, Southeast Region
Mitch McCahey
Sales Director, West Region
John Rumberger
Medical Advisor
Irfan Shafique
Medical Advisor
06 · Company updates
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07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies applying AI to cardiovascular disease detection, ECG/EKG analysis, heart failure management, cardiac imaging, arrhythmia detection, or cardiovascular risk assessment. Includes AI-powered cardiac diagnostics, non-invasive hemodynamic monitoring, and tools for early detection and personalized management of heart conditions.
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