Philips Takes Ultrasound Into the AI Workflow Era with FDA Clearance for Elevate Plus

Philips has received FDA 510(k) clearance for Elevate Plus, an AI-enabled upgrade to its EPIQ Elite and Affiniti ultrasound systems, alongside CE mark approval in Europe.

The update brings a clear strategic message: ultrasound is no longer just an imaging modality — it is becoming an AI-assisted workflow platform designed to standardise clinical decision-making at scale

At its core, Elevate Plus combines automation, image enhancement, and embedded decision support tools to reduce variability in routine examinations and improve consistency across operators and care settings.

Moving From Imaging to Intelligent Workflow

Ultrasound has traditionally been highly operator-dependent, with image quality and interpretation varying significantly based on clinician experience.

Philips is positioning Elevate Plus as a response to that challenge.

The upgrade introduces AI-driven workflow automation features designed to streamline routine exams and reduce the need for repeat scans, particularly in high-volume clinical environments.

A key component is Auto Measure Abdomen, an AI tool that automates common abdominal measurements during scanning.

Philips reports accuracy rates above 93% when compared with manual expert readings, suggesting a growing level of reliability in automated clinical measurement.

The objective is not to replace clinicians, but to reduce repetitive tasks and minimise variation in routine workflows.

AI Decision Support Moves Onto the Ultrasound Cart

A notable shift with Elevate Plus is the integration of Koios AI decision support tools directly on-cart within the ultrasound systems.

Previously, these tools were only available off-cart and limited to Philips-generated images.

Now, clinicians can perform real-time lesion classification during the scan itself, including: ~

• Breast lesion classification using Koios BI-RADS

• Thyroid nodule assessment using Koios TI-RADS
  

These models are trained on large datasets of pathology-confirmed cases, enabling rapid risk stratification at the point of imaging.

This shift brings AI closer to the point of clinical decision-making, rather than treating it as a downstream analytical tool.

Enhancing Image Quality With AI-Based Processing

Alongside workflow automation, Elevate Plus introduces new imaging enhancements designed to improve clarity and diagnostic confidence.

These include:

• XRes Pro+: enhancing tissue detail and boundary definition

• Super Res MVI Pro: improving microvascular flow visualisation
  

Together, these tools aim to make subtle anatomical and vascular features easier to interpret, particularly in complex or fast-paced clinical environments.

The emphasis is on consistency — ensuring that image quality is less dependent on operator skill and more standardised across systems and users.

Why This Matters for Clinical Imaging

Ultrasound sits at the intersection of high clinical utility and high variability.

It is widely used, relatively low-cost, and highly versatile — but historically dependent on operator expertise for both image acquisition and interpretation.

AI-enabled systems like Elevate Plus represent a shift toward:

• Standardised imaging quality across healthcare settings

• Reduced repeat scanning and improved workflow efficiency

• Earlier integration of diagnostic support during the exam itself

• Greater consistency in high-volume diagnostic environments
  

As healthcare systems face increasing demand, these efficiency gains become structurally important rather than merely incremental improvements.

A Broader Strategic Direction in Medical Imaging

Philips’ latest clearance reflects a wider industry trend: imaging platforms are evolving into integrated diagnostic ecosystems.

Rather than separate tools for acquisition, analysis, and interpretation, companies are increasingly embedding AI directly into imaging hardware to support real-time decision-making.

This moves ultrasound closer to a fully assisted diagnostic workflow, where automation supports clinicians throughout the entire examination process.

Summary

The FDA clearance of Philips’ Elevate Plus marks another step in the evolution of ultrasound from a manual imaging tool to an AI-powered diagnostic workflow platform.

By combining automated measurements, embedded decision support, and enhanced imaging quality, Philips is aiming to reduce variability, improve efficiency, and support more consistent clinical outcomes across high-demand healthcare environments.

More broadly, the upgrade highlights a clear direction for medical imaging: tighter integration between AI, hardware, and clinical decision-making at the point of care.

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