Philips receives FDA 510(k) clearance for Elevate Plus for EPIQ Elite and Affiniti, delivering AI advancements in general imaging ultrasound
Rhea-AI Summary
Philips (NYSE: PHG) received FDA 510(k) clearance for Elevate Plus on its EPIQ Elite and Affiniti ultrasound systems, adding AI-powered workflow and imaging enhancements. Elevate Plus, which also has CE Mark, offers Auto Measure Abdomen with over 93% accuracy and reported scanning time reductions of up to 30%.
Integrated Koios AI decision support enables rapid Bi-RADS and Ti-RADS lesion classification, while new imaging tools like XRes Pro+ and Super Res MVI Pro support clearer visualization. A modular, upgradable platform aims to extend system lifespan and support remote updates and tele-health workflows.
AI-generated analysis. Not financial advice.
Positive
- FDA 510(k) clearance for Elevate Plus on EPIQ Elite and Affiniti
- Auto Measure Abdomen delivers over 93% measurement accuracy versus clinical experts
- Customer evaluation reports up to 30% reduction in scanning time
- Koios AI support uses over 350,000 pathology-proven cases for lesion assessment
- Modular, upgradable platform designed to extend ultrasound system lifespan
Negative
- None.
News Market Reaction – PHG
On the day this news was published, PHG declined 2.49%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
PHG slipped 1.17% while key device peers were mixed: STE and SNN down, DXCM, PODD, and ZBH up. Momentum scanner flagged EW down 4.62% without news, pointing to stock‑specific, not broad AI or device-driven, pressure.
Previous AI Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 16 | AI CT clearance | Positive | -1.6% | FDA 510(k) clearance for AI-powered Spectral CT Verida system. |
| Dec 01 | AI navigation rollout | Positive | +0.6% | Expanded LumiGuide AI 3D navigation availability across EU and US. |
| Nov 30 | AI CT launch | Positive | +0.6% | Launch of AI-powered Verida spectral CT with energy savings claims. |
| Nov 17 | AI valve guidance | Positive | -2.4% | Introduction of DeviceGuide AI tracking for mitral valve repair support. |
| Sep 17 | AI MRI deployment | Positive | -0.5% | AI-enabled MRI deployment at Southlake Health to boost imaging capacity. |
AI-focused announcements often read as strategically positive but have produced mixed to slightly negative next-day moves.
Recent AI news for Philips has centered on bringing advanced, FDA- and CE-cleared imaging platforms into routine care. Events included Verida spectral CT clearance on Apr 16, 2026, expansion of LumiGuide 3D navigation, and AI-assisted cardiac procedure tools like DeviceGuide. These AI milestones span CT, interventional cardiology, and MRI capacity. Today’s Elevate Plus ultrasound AI clearance extends that pattern into general imaging workflows and on-cart decision support.
Historical Comparison
AI-tagged headlines have led to an average next-day move of -0.67%, showing that clinically positive AI imaging news has not consistently translated into strong upside reactions.
AI initiatives have progressed from MRI workflow and CT spectral imaging to real-time navigation and cardiac guidance; Elevate Plus extends this AI footprint into general ultrasound exams and on-cart decision support.
Market Pulse Summary
This announcement adds an FDA 510(k)-cleared AI layer to Philips’ EPIQ Elite and Affiniti ultrasound systems, targeting faster, more consistent exams with over 93% measurement accuracy and up to 30% time savings. In context of earlier AI imaging launches across CT, MRI, and interventional platforms, it reinforces a broad AI roadmap. Investors may track adoption rates, clinician workflow impact, and how these premium features influence future ultrasound replacement and upgrade cycles.
Key Terms
fda 510(k) clearance regulatory
ce mark regulatory
ai-powered technical
bi-rads medical
ti-rads medical
microvascular medical
tele-health technical
retrospective data analysis medical
AI-generated analysis. Not financial advice.
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
“Elevate Plus is a game‑changer for our ultrasound workflow. Automating key measurement tasks allows our sonographers to reduce scanning time by up to
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.
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