Philips receives FDA 510(k) clearance for Elevate Plus for EPIQ Elite and Affiniti, delivering AI advancements in general imaging ultrasound

02 Jun 2026 15:00 CEST

June 2, 2026 

Philips receives FDA 510(k) clearance for Elevate Plus for EPIQ Elite and Affiniti, delivering AI advancements in general imaging ultrasound

AI-powered workflow automation helps clinicians acquire high-quality reproducible images faster and with greater confidence

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced regulatory clearance in the USA of Elevate Plus, bringing advanced imaging and a suite of AI and automation capabilities to Philips EPIQ Elite and Affiniti, its flagship ultrasound systems. With CE Mark and 510(k) clearance, Elevate Plus helps standardize routine exams and reduce the need for repeat scanning, delivering more consistent and high-quality ultrasound images faster across users. This expands Philips’ leadership in AI-powered ultrasound, helping care teams manage growing demand and staffing pressures.

“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 help clinicians deliver 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, helping to reduce variability and save significant time which is critical in high-volume settings and dynamic exams. Decisions can be made with confidence as measurements deliver over 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, RDMS, RMSKS, Ultrasound Manager, 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 the risk of malignancy in under 2 seconds, and also leverages Koios Ti-RADS software to support confident lesion classifications using over 350,000 pathology-proven cases. Previously Koios AI decision support was only compatible with Philips Ultrasound images off-cart and uniquely delivered fully automated reporting with smart calipers.

Advanced image quality enables 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, helping to give clinicians clearer insights into blood flow with greater clarity, supporting efficient exams with fewer repeat scans.

Built to evolve: Long-term value with modular, upgradable technology
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. Remote updates and security enhancements help keep technology current with minimal disruption, while built‑in tele-health 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, Hospital das Clínicas, School of Medicine, University of São Paulo - 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.” 

Learn more about Elevate Plus here.

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

For further information, please contact:

Jayme Maniatis
Philips Global External Relations 
Tel.: +1 617-894-8368
E-mail: jayme.maniatis@philips.com

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home.

Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2025 sales of approximately EUR 18 billion and employs approximately 64,300 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Attachment

• Philips Elevate Plus AI Powered Ultrasound