Philips has received the US Food and Drug Administration (FDA) 510(k) clearance for Elevate Plus, an upgrade that adds new imaging and AI capabilities to its EPIQ Elite and Affiniti ultrasound systems.
The company confirmed it has also received the CE mark in Europe for Elevate Plus, allowing it to offer these imaging advancements in two major markets.
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With these clearances, Philips aims to introduce workflow automation and image quality features to its general imaging ultrasound products, aiming to help standardise routine examinations and reduce the need for repeat scanning.
Elevate Plus is designed to deliver more consistent images at faster speeds across different healthcare staff. The upgrade includes AI-based tools such as Auto Measure Abdomen, meant to automate common abdominal measurement procedures.
The company reports that this application achieves accuracy rates greater than 93% when compared to manual readings by clinical experts.
Philips said this automation could help limit variability between operators and save time, particularly in busy or high-volume environments.
For lesion classification, Koios AI decision support is now integrated on-cart within EPIQ Elite and Affiniti ultrasound units.
This allows clinicians to classify breast lesions and thyroid nodules during the exam, using Koios Bi-RADS for rapid risk assessment and Koios Ti-RADS for lesion classification, both trained on large datasets of pathology-confirmed cases.
These tools were previously available only off-cart and compatible solely with Philips Ultrasound-generated images.
New imaging enhancements launched with Elevate Plus are intended to support clinicians in visualising complex anatomical features and blood flow.
Functions such as XRes Pro+ provide cleaner tissue detail and sharper imaging boundaries while Super Res MVI Pro aims to improve microvascular flow assessment, which may lead to more efficient examinations.
Philips precision diagnosis chief business leader Jie Xue said: “Elevate Plus underscores our commitment to advancing AI-powered ultrasound to help clinicians deliver more consistent, efficient, and confident ultrasound care to patients.”
“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.”
