Philips obtains FDA approval for Elevate Plus AI ultrasound enhancement

THE NETHERLANDS—Royal Philips has received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark certification for Elevate Plus, an AI-powered enhancement for its EPIQ Elite and Affiniti ultrasound systems.

The approval marks another step in Philips’ strategy to integrate advanced AI and automation into medical imaging workflows, helping healthcare providers improve efficiency while maintaining diagnostic accuracy.

The newly cleared technology aims to standardize routine ultrasound examinations, reduce variability between operators, and minimize the need for repeat scans.

As healthcare systems worldwide continue to face rising patient volumes and workforce shortages, Philips says Elevate Plus will help clinicians acquire high-quality images more quickly and consistently, regardless of experience level.

AI automation targets workflow bottlenecks

One of the key features introduced through Elevate Plus is Auto Measure Abdomen, an AI-driven tool that automates routine abdominal measurements.

Ultrasound measurements often depend heavily on operator expertise and can vary from one clinician to another.

By automating these repetitive tasks, the software helps reduce inconsistencies while accelerating examination times.

According to Philips, the tool delivers more than 93% measurement accuracy when compared with manual assessments performed by clinical experts.

The company believes this capability could prove especially valuable in busy imaging departments where clinicians must balance growing workloads with the need for reliable diagnostic results.

Gretchen Sammy, Ultrasound Manager at Boston Medical Center, said the technology significantly improved workflow efficiency during evaluations.

She noted that automating measurement tasks enabled sonographers to reduce scanning time by up to 30% while maintaining the clinical precision required for patient care.

Enhanced decision support for breast and thyroid imaging

Philips has also integrated Koios AI decision-support technology directly onto EPIQ Elite and Affiniti systems.

Previously available only as an off-cart solution, the software now allows clinicians to assess breast lesions and thyroid nodules directly during examinations.

The platform incorporates Koios Bi-RADS technology, which can evaluate the likelihood of malignancy in less than two seconds, while Koios Ti-RADS supports thyroid lesion classification using data derived from more than 350,000 pathology-confirmed cases.

By embedding these capabilities into the ultrasound system, Philips aims to streamline workflows and support faster clinical decision-making.

Improved visualization in challenging cases

In addition to workflow automation, Elevate Plus introduces imaging enhancements designed to improve visualization of anatomy and blood flow.

XRes Pro+ delivers sharper tissue detail and clearer anatomical boundaries, helping clinicians obtain more consistent images across a broad range of patient body types.

Meanwhile, Super Res MVI Pro improves visualization of microvascular blood flow, providing clinicians with clearer insights into vascular structures and potentially reducing the need for repeat examinations.

These enhancements are intended to help healthcare professionals reach diagnostic conclusions more quickly, particularly in complex or technically demanding cases.

Built for long-term flexibility

Philips designed Elevate Plus as part of a modular and upgradeable ultrasound platform that can evolve alongside changing clinical requirements.

Remote software updates, cybersecurity enhancements, and built-in telehealth support allow healthcare organizations to keep systems current while minimizing operational disruptions.

Maria Cristina Chammas, Director of the Ultrasound Division at Hospital das Clínicas, School of Medicine, University of São Paulo, said the AI-driven automation could help reduce sonographer fatigue by eliminating repetitive manual tasks while promoting greater consistency across clinical teams.

Philips strengthens broader AI healthcare strategy

The Elevate Plus launch comes as Philips continues to expand its AI-focused healthcare portfolio.

Earlier this month, the company released findings from its Future Health Index 2026 survey, which showed that healthcare professionals are increasingly using AI to improve efficiency, reduce errors, and increase patient throughput.

According to the survey, clinicians reported seeing a median of 5 additional patients per week with AI support, and many also cited improvements in productivity and workflow performance.

However, the study highlighted ongoing challenges related to AI training and workforce readiness.

The company has also recently announced a strategic alliance with WellSpan Health in the United States to accelerate healthcare innovation and research, further reinforcing its commitment to expanding AI-enabled technologies across imaging, diagnostics, patient monitoring, and clinical decision support.