FDA Clears Philips’ Elevate Plus for EPIQ Elite and Affiniti

Royal Philips has secured U.S. Food and Drug Administration 510(k) clearance for Elevate Plus, expanding the capabilities of its flagship Philips EPIQ Elite and Affiniti ultrasound systems with advanced imaging, artificial intelligence (AI), and automation technologies.

With both CE Mark and 510(k) clearance, Elevate Plus helps standardize routine exams and reduce the need for repeat scanning, thus delivering more consistent and high-quality ultrasound images faster.

“Elevate Plus underscores our commitment to advancing AI-powered ultrasound to help clinicians deliver more consistent, efficient, and confident ultrasound care to patients,” said Jie Xue, chief business leader, Precision Diagnosis, Philips. “By combining intelligent imaging with AI-powered workflow automation across our ultrasound platform, Elevate Plus is designed to reduce variability, streamline routine exams, and support faster, more informed clinical decisions as care teams face growing demand.”

AI-Powered Workflow Enhancements for Consistent Ultrasound Care

Performing abdominal measurements is often complex, time-consuming, and highly operator-dependent, leading to variability across users and settings. Auto Measure Abdomen, as part of Elevate Plus, uses AI to help automate routine measurement steps, reducing variability and saving significant time—which is critical in high-volume settings and dynamic exams. Decisions can be made with confidence as measurements deliver more than 93% accuracy compared to manual measurements by clinical experts.¹

“Elevate Plus is a game changer for our ultrasound workflow. Automating key measurement tasks allows our sonographers to reduce scanning time by up to 30% without sacrificing clinical precision,” said Gretchen Sammy, ultrasound manager at Boston Medical Center. “During our evaluation, measurements were consistently placed exactly where we would expect them—saving time while maintaining the accuracy we rely on.”

Koios AI decision support, previously available off-cart, is now available on-cart for EPIQ Elite and Affiniti ultrasound systems, enabling clinicians to classify breast lesions and thyroid nodules. Philips Ultrasound integrates with Koios Bi-RADs, which offers interpretation and assessment of malignancy risk in less than two seconds, and also leverages Koios Ti-RADS software to support confident lesion classifications using more than 350,000 pathology-proven cases. Previously, Koios AI decision support was only compatible with Philips Ultrasound images off-cart and delivered fully automated reporting with smart calipers.

Clearer Visualization and Confident Decisions

New imaging enhancements are designed to help clinicians reach confident answers faster, especially in challenging exams, by making anatomy and flow easier to visualize. XRes Pro+ can deliver cleaner tissue detail and sharper boundaries, supporting more consistent imaging across a wide range of patient body types. Super Res MVI Pro is designed to enhance microvascular flow visualization, giving clinicians clearer insights into blood flow with better clarity, supporting efficient exams with fewer repeat scans.

Healthcare organizations require ultrasound systems that can adapt as demands evolve. EPIQ Elite and Affiniti Elevate Plus deliver long‑term value through a modular, upgradable platform designed to extend system lifespan, according to Philips. Remote updates and security enhancements help keep technology current with minimal disruption, while built‑in telehealth support promotes consistency across care teams and sites.

“By automating key measurement tasks with AI, Elevate Plus has the potential to significantly reduce scanning time while maintaining clinical accuracy,” said Maria Cristina Chammas, director of Ultrasound Division at Hospital das Clínicas, School of Medicine, University of São Paulo in São Paulo, Brazil. “This can help improve workflow efficiency and reduce the repetitive manual steps that contribute to sonographer fatigue, while supporting more consistent results across our team.” 

Royal Philips is a global health technology company leveraging advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers. Headquartered in the Netherlands, the company develops solutions in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated approximately €18 billion in 2025 sales and employs roughly 64,300 workers with sales and services in more than 100 countries.

Reference
¹ Obtained from a retrospective data analysis study involving data from 150 subjects (using MD.AI annotation tool, 3 clinical experts)