AMSTERDAM, Netherlands, June 2, 2026
Royal Philips has received U.S. FDA 510(k) clearance and CE Mark approval for Elevate Plus, a next-generation upgrade designed for its flagship EPIQ Elite and Affiniti ultrasound systems, introducing advanced artificial intelligence capabilities, workflow automation, and enhanced imaging performance. The newly cleared platform aims to help healthcare providers deliver faster, more consistent, and higher-quality ultrasound examinations while addressing growing workforce shortages and increasing patient demand. By combining intelligent imaging technologies with AI-driven measurement automation and decision-support tools, Philips continues to strengthen its position in the rapidly evolving field of AI-powered medical imaging. The regulatory milestone highlights the growing role of artificial intelligence in improving diagnostic efficiency, reducing operator variability, and supporting more confident clinical decision-making across a wide range of ultrasound applications.
AI-Powered Automation Enhances Ultrasound Workflow Efficiency
A key innovation within Elevate Plus is its suite of workflow automation tools designed to simplify routine imaging procedures and reduce manual measurement burdens. Among the most significant advancements is Auto Measure Abdomen, an AI-powered feature that automates abdominal measurements, one of the most time-consuming and operator-dependent aspects of ultrasound examinations. According to Philips, the technology delivers more than 93% measurement accuracy compared with expert manual assessments, helping clinicians obtain reproducible results with greater consistency.
Healthcare providers evaluating the system reported scanning time reductions of up to 30%, enabling sonographers to complete examinations more efficiently without compromising diagnostic precision. By reducing repetitive manual tasks and minimizing measurement variability, Elevate Plus has the potential to improve workflow efficiency while helping address challenges associated with sonographer fatigue and increasing imaging volumes in hospitals and diagnostic centers worldwide.
Advanced Imaging and AI Decision Support Strengthen Diagnostics
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Beyond workflow automation, Elevate Plus introduces a range of advanced imaging enhancements designed to improve visualization of anatomical structures and blood flow. The new XRes Pro+ imaging technology delivers cleaner tissue detail and sharper image boundaries, supporting clearer visualization across a broader range of patient body types. Philips has also incorporated Super Res MVI Pro, which enhances microvascular flow imaging and enables clinicians to assess blood flow patterns with improved clarity and confidence.
Additionally, the company has integrated Koios AI decision-support technology directly onto EPIQ Elite and Affiniti ultrasound platforms, eliminating the need for separate off-cart analysis. The solution assists clinicians in evaluating breast lesions and thyroid nodules, providing rapid malignancy risk assessments in less than two seconds. Leveraging a database of more than 350,000 pathology-proven cases, the system supports standardized lesion classification while streamlining reporting workflows, helping clinicians make more informed diagnostic decisions in real time.
Designed for Long-Term Value and Future Healthcare Needs
Philips developed Elevate Plus as part of a modular and upgradable ultrasound platform strategy that enables healthcare organizations to maximize technology investments while adapting to future clinical demands. The system supports remote software updates, cybersecurity enhancements, and telehealth capabilities, allowing hospitals and imaging centers to maintain up-to-date performance with minimal operational disruption. These features are increasingly important as healthcare providers seek scalable technologies capable of supporting distributed care models and growing diagnostic workloads.
Industry experts believe AI-enabled ultrasound platforms will play a critical role in the future of medical imaging by improving consistency, accelerating examinations, and enhancing diagnostic confidence across care settings. With FDA clearance now secured, Elevate Plus positions Philips to further expand the adoption of artificial intelligence in ultrasound while helping clinicians deliver faster, more accurate, and more efficient patient care. The launch also reflects the broader transformation of diagnostic imaging through automation and machine learning technologies designed to improve healthcare outcomes worldwide.
Source: Philips press release
