Certification opens the European market for the first FDA-cleared AI platform for prostate MRI interpretation. OMAHA, Neb., Oct. 27, 2025 /PRNewswire/ -- Bot Image, Inc., a leader in AI-powered ...
Lumea’s Viewer+™ software is now CE marked under IVDR for clinical use across Europe, making Lumea the most versatile ...
Approvals mark a major milestone and bring the most advanced image quality to date to Swoop® system users in European markets GUILFORD, Conn.--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the ...
GE HealthCare has gained 501(k) clearance from the US Food and Drug Administration (FDA) for its CleaRecon DL technology, as well as a European CE Mark. An AI-based technology for improving the ...
CLEVELAND, Dec. 1, 2025 /PRNewswire/ -- MediView XR, Inc., a pioneer in clinical augmented reality and spatial computing, proudly announced its first CE mark certification, a significant regulatory ...
Expanded Intelligent Surgical Unit™ (ISU™) capabilities include 3D measurement, digital tagging, image enhancement, and enhanced camera control, for our European customers RESEARCH TRIANGLE PARK, N.C.
The Genius Digital Diagnostics System now offers European labs the ability to streamline digital pathology workflows using one complete solution for a variety of specimen types MARLBOROUGH, ...
Imagine Eyes, a medical device manufacturer based in Orsay, France, received CE Mark approval in the European Union for its new retinal imaging system. According to information released by the company ...
This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...
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