Royal Philips, a global leader in health technology, announced today that it has received FDA 510(k) clearance for Elevate Plus, a new software package that brings advanced artificial intelligence and automation capabilities to its flagship EPIQ Elite and Affiniti ultrasound systems. The clearance marks a significant step in expanding Philips' leadership in AI-powered ultrasound, helping clinicians manage growing demand and staffing pressures.
AI-Powered Workflow Automation
Elevate Plus is designed to standardize routine exams and reduce the need for repeat scanning. By integrating intelligent imaging with AI-driven workflow automation, the system helps clinicians acquire high-quality, reproducible images faster and with greater confidence. This is particularly critical in high-volume settings where time and consistency are paramount.
Auto Measure Abdomen
One of the key features of Elevate Plus is Auto Measure Abdomen, which uses AI to automate routine measurement steps. Abdominal measurements are often complex, time-consuming, and highly operator-dependent, leading to variability across users. The new tool helps reduce variability and saves significant time, with measurements achieving over 93% accuracy compared to manual measurements by clinical experts.
On-Cart AI Decision Support
Elevate Plus also integrates Koios AI decision support directly on the cart for EPIQ Elite and Affiniti systems. Previously available only off-cart, this feature enables clinicians to classify breast lesions and thyroid nodules using Koios Bi-RADs and Ti-RADS software. The AI provides interpretation and risk assessment of malignancy in under two seconds, leveraging over 350,000 pathology-proven cases.
Clinical Impact
“Elevate Plus is a game-changer for our ultrasound workflow,” said Gretchen Sammy, RDMS, RMSKS, Ultrasound Manager at Boston Medical Center. “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.”
Jie Xue, Chief Business Leader of Precision Diagnosis at Philips, added: “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.”
With both CE Mark and FDA 510(k) clearance, Elevate Plus is now available for Philips EPIQ Elite and Affiniti ultrasound systems, expanding access to AI-driven tools that help standardize care and improve patient outcomes.
