Philips Receives Regulatory Clearance for Elevate Plus in the USA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 02 2026
0mins
Philips 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 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.
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About PHG
Koninklijke Philips NV is a Netherlands-based health technology company. The Company's segments include Personal Health businesses, Diagnosis & Treatment businesses, Connected Care businesses and Other. The Personal Health businesses segment is engaged in the health continuum, delivering integrated, connected solutions that support healthier lifestyles and those living with chronic disease as well as oral healthcare and mother and child care support. The Diagnosis & Treatment businesses segment delivers precision medicine and treatment, and therapy. The Connected Care businesses segment provides consumers, care givers and clinicians with digital solutions that facilitate care by enabling precision medicine and population health management. The Other segment comprises such items, as innovation, emerging businesses, royalties, among others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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See More
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- Significant Time Savings: Nearly half of clinicians (49%) reported saving at least 132 hours annually, equivalent to over three full working weeks, allowing them to focus more on high-value clinical tasks and improving the quality of medical decision-making.
- Enhanced Safety: Over one-quarter of healthcare professionals (27%) indicated that AI helped them identify or prevent potential medical errors at least three times in the past three months, underscoring AI's critical role in supporting safer care and clinical decision-making.
- Improved Job Satisfaction: 35% of clinicians reported better work-life balance, 36% noted reduced work-related stress, and 32% experienced less overtime or taking work home, indicating a positive impact of AI on the overall well-being of healthcare workers.
See More
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- Significant Time Savings: AI saves clinicians the equivalent of 16 working days annually, with nearly half reporting the ability to see eight more patients weekly, thereby enhancing the efficiency and quality of healthcare services.
- Error Prevention: 39% of clinicians report that AI has identified or prevented potential medical errors at least three times in the past three months, which not only improves patient safety but also boosts clinicians' confidence in decision-making.
- Urgent Training Needs: While 59% of clinicians believe their organization's leadership is taking the right steps to implement AI, 70% report inadequate or inconsistent training, indicating significant organizational readiness gaps in AI integration.
- Increased Patient Engagement: 74% of clinicians note that patients arrive at consultations AI-informed, with 63% considering informed patients as integral future partners in the healthcare team, enhancing patient engagement and the quality of care.
See More
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- Co-Development of Products: Under the agreement, Philips and WellSpan will co-develop new healthcare products and features leveraging Philips' R&D pipeline, which will not only enhance WellSpan's medical service capabilities but also drive product innovation for Philips in the healthcare market.
- Preferred Vendor Status: Philips will become WellSpan's preferred vendor for imaging modalities including CT, MRI, digital X-ray, ultrasound, and image-guided therapy systems, covering all 12 WellSpan hospitals and diagnostic imaging centers, which is anticipated to increase Philips' market share.
- Research and Innovation Strategy: The collaboration includes a research agreement and joint innovation strategy to evaluate AI and digital health tools designed to improve workflow efficiency, throughput, and cost management, thereby providing long-term business growth potential for both parties.
See More
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- Innovation and R&D Focus: The collaboration will focus on validating the performance of new tools and technologies, with expectations to improve throughput and workflow efficiency through AI and digital tools, helping WellSpan reclaim over 500,000 hours of workforce time annually, significantly enhancing operational efficiency.
- Long-term Commercial Agreement: Philips has been designated as WellSpan's preferred vendor across all imaging modalities, covering 12 hospitals and diagnostic imaging centers, ensuring a consistent patient experience across locations and reducing access barriers for patients.
- Transforming Future Care: By combining Philips' technological leadership with WellSpan's clinical expertise, this collaboration aims to drive measurable improvements in patient care quality and operational performance, establishing a scalable AI-driven platform that shapes the future of care delivery.
See More
Philips Secures FDA Clearance for Elevate Plus Ultrasound System
- AI Advancements: Philips' Elevate Plus has received FDA 510(k) clearance, integrating AI and automation capabilities to enhance ultrasound imaging quality and consistency, thereby enabling clinicians to conduct examinations more efficiently in high-demand settings.
- Measurement Automation: The Auto Measure Abdomen feature of Elevate Plus automates routine measurement steps using AI, reducing scanning time by up to 30% while maintaining 93% accuracy, significantly improving workflow efficiency in ultrasound operations.
- Integrated Decision Support: The Koios AI decision support system is now integrated into the EPIQ Elite and Affiniti ultrasound systems, allowing for rapid assessment of breast lesions and thyroid nodules' malignancy risk in under 2 seconds, enhancing clinical decision-making confidence and speed.
- Long-Term Value: The EPIQ Elite and Affiniti Elevate Plus systems are designed with modular technology that supports remote updates and security enhancements, ensuring ongoing adaptability and relevance to meet evolving healthcare demands.
See More
