Philips announced that it has obtained FDA clearance for Elevate Plus, an expanded suite of advanced imaging, artificial intelligence and automation capabilities designed for its flagship EPIQ Elite and Affiniti ultrasound platforms. The company said the technology, which already holds CE mark certification and 510(k) clearance, is intended to help standardize routine examinations, reduce the need for repeat scans and support the delivery of consistent, high-quality imaging across different users. Originally introduced in February 2025, the platform extends Philips’ efforts to advance AI Ultrasound applications in clinical settings by combining imaging enhancements with workflow automation tools.
Among the newly cleared capabilities is Auto Measure Abdomen, an AI-enabled feature developed to automate routine measurement tasks during examinations. Philips said the technology can help reduce variability in measurements while saving time for clinicians. The company also expanded access to Koios AI decision-support tools, which were previously available off-cart. The functionality is now integrated directly into EPIQ Elite and Affiniti systems, allowing clinicians to classify breast lesions and thyroid nodules within the ultrasound workflow. According to Philips, integration with Koios Bi-RADS enables interpretation and malignancy risk assessment in less than two seconds.
The Elevate Plus package also introduces imaging upgrades aimed at improving visualization of anatomy and blood flow. Philips said XRes Pro+ provides cleaner tissue detail and sharper anatomical boundaries, helping create more consistent images across different body types. In addition, Super Res MVI Pro enhances visualization of microvascular flow, giving clinicians greater clarity when assessing blood circulation and vascular structures. These enhancements are designed to improve image quality while supporting more efficient diagnostic workflows.
Commenting on the clearance, Jie Xue, chief business leader, Precision Diagnosis, Philips, 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.”
Gretchen Sammy, ultrasound manager at Boston Medical Center, stated: “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. During our evaluation, measurements were consistently placed exactly where we would expect them saving time while maintaining the accuracy we rely on.”
Maria Cristina Chammas, director of ultrasound at Hospital das Clínicas, School of Medicine, University of São Paulo, added that AI Ultrasound automation could help shorten scanning times, improve workflow efficiency and reduce repetitive manual tasks that contribute to sonographer fatigue while supporting more consistent clinical results.
