New LaunchJun 2, 2026, 09:01 AM
Philips Receives FDA Clearance for AI-Powered Elevate Plus Ultrasound Software
AI Summary
Koninklijke Philips NV announced it has received FDA 510(k) clearance for its Elevate Plus software for its EPIQ Elite and Affiniti ultrasound systems. This clearance brings advanced AI and automation capabilities to the flagship ultrasound systems, aiming to standardize routine exams, reduce the need for repeat scanning, and deliver more consistent, high-quality images faster. The AI-powered features, including Auto Measure Abdomen and integrated Koios AI decision support, are designed to streamline workflows, improve diagnostic confidence, and help care teams manage growing demand and staffing pressures.
Key Highlights
- Philips received FDA 510(k) clearance for Elevate Plus, enhancing EPIQ Elite and Affiniti ultrasound systems with AI.
- AI-powered workflow automation in Elevate Plus helps clinicians acquire high-quality images faster and with greater confidence.
- Auto Measure Abdomen feature uses AI to automate routine measurement steps, reducing variability and saving time.
- Koios AI decision support is now available on-cart for EPIQ Elite and Affiniti systems, aiding in breast and thyroid nodule classification.
- Advanced imaging enhancements like XRes Pro+ and Super Res MVI Pro improve visualization and clarity of anatomy and flow.
- The modular and upgradable platform of Elevate Plus is designed to extend system lifespan and adapt to evolving demands.
Price Impact
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