• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Special Reports
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Resources
    • About MassDevice
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
    • In-Depth Coverage
    • Latest News
  • Attend DeviceTalks
    • Events
      • DeviceTalks Minnesota – May 4
      • DeviceTalks Boston – May 27–28
      • DeviceTalks West
      • DeviceTalks Tuesdays
    • DeviceTalks Podcast Network
      • DeviceTalks Weekly
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Advertise
  • Subscribe
Home » Philips wins FDA clearance for AI-powered ultrasound workflow tech

Philips wins FDA clearance for AI-powered ultrasound workflow tech

June 2, 2026 By Sean Whooley

Philips Elevate Plus AI Ultrasound
The Elevate Plus AI-powered ultrasound system in use. [Image courtesy of Philips]
Philips (NYSE:PHG) announced today that it received FDA clearance for its Elevate Plus advanced imaging and AI and automation capabilities.

Elevate Plus brings its advanced technology suite and capabilities to the company’s flagship EPIQ Elite and Affiniti ultrasound systems. It holds CE mark and 510(k) clearance to help standardize routine exams and reduce the need for repeat scanning. This helps to deliver more consistent, high-quality ultrasound images faster across users.

Amsterdam-based Philips originally unveiled its Elevate software in February 2025.

Features of the platform include AI-powered workflow enhancements for consistent ultrasound care. Auto Measure Abdomen uses AI to help automate routine measurement steps, reducing variability and saving time.

Meanwhile, Koios AI decision support, previously available off-cart, is now available on-cart for EPIQ Elite and Affiniti systems. This helps clinicians classify breast lesions and thyroid nodules, Philips says, while its ultrasound integrates with Koios Bi-RADS, offering interpretation and assessment of risk of malignancy in under two seconds.

Philips also said new imaging enhancements deliver easier visualization for anatomy and flow. Its XRes Pro+ offers cleaner tissue detail and sharper boundaries for more consistent imaging across body times. Super Res MVI Pro, meanwhile, enhances microvascular flow visualization to enable greater clarity around blood flow.

Commentary from Philips officials and clinicians

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, Boston Medical Center, said:

“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 (Brazil), said:

“By automating key measurement tasks with AI, Elevate Plus has the potential to significantly reduce scanning time while maintaining clinical accuracy. This can help improve workflow efficiency and reduce the repetitive manual steps that contribute to sonographer fatigue, while supporting more consistent results across our team.”

Filed Under: 510(k), Artificial Intelligence (AI), Food & Drug Administration (FDA), Health Technology, Imaging, Machine Learning (ML), Regulatory/Compliance, Software / IT, Ultrasound Tagged With: FDA, Philips

More recent news

  • Citi downgrades Boston Scientific as cyberattack recovery compounds competitive pressure
  • Autonomix taps former Medtronic FDA counsel head for board of directors
  • Medtronic strengthens robotic surgery position with Cornerstone deal, analysts say
  • Science Corp. names president as it looks to roll out vision-restoring implant
  • Mindray looks to fill hospital ventilator gap left by Philips’ exit

About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

Primary Sidebar

Cart

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >
MDO ad
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2026 · Arrowfly LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of Arrowfly.

Privacy Policy