Over 150 Total Lots Up For Auction at One Location - MO 06/05

Philips receives FDA 510(k) clearance for Elevate Plus for EPIQ Elite and Affiniti ultrasound systems

Press releases may be edited for formatting or style | June 02, 2026 Ultrasound
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
stats Advertisement
DOTmed text ad

Training and education based on your needs

Stay up to date with the latest training to fix, troubleshoot, and maintain your critical care devices. GE HealthCare offers multiple training formats to empower teams and expand knowledge, saving you time and money.

stats
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 93% accuracy compared to manual measurements by clinical experts [1].

“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,” said Gretchen Sammy, RDMS, RMSKS, Ultrasound Manager, Boston Medical Center. “During our evaluation, measurements were consistently placed exactly where we would expect them—saving time while maintaining the accuracy we rely on.”

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.

You Must Be Logged In To Post A Comment