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GE HealthCare unveils enhanced Voluson Expert Series women’s health ultrasound systems with focus on early detection and exam efficiency

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GE HealthCare (GEHC) has received FDA 510(k) clearance for its updated Voluson Expert Series ultrasound systems. The new series, comprising Voluson Expert 22, 20, and 18, combines high-resolution imaging with AI-powered features and automation tools designed for women's healthcare.

The systems feature Lyric Architecture for detailed imaging and include enhanced AI tools like SonoLyst for automated annotations and measurements during 11-14 week anatomical exams. Notable improvements include Graphicflow for blood flow visualization and upgraded tools like SonoPelvicFloor3.0, which reduces pelvic floor measurement exam time by 80%, and SonoAVCfollicle2.0 for improved follicle detection.

This development addresses a critical healthcare need, as approximately 30,000 to 50,000 women in the United States experience complex, high-risk pregnancies annually. The systems will be showcased at the SMFM 2025 Pregnancy Meeting in Denver.

GE HealthCare (GEHC) ha ricevuto l'autorizzazione FDA 510(k) per i suoi aggiornati sistemi ecografici Voluson Expert Series. La nuova serie, composta dai modelli Voluson Expert 22, 20 e 18, unisce immagini ad alta risoluzione a funzionalità potenziate dall'IA e strumenti di automazione progettati per la salute delle donne.

I sistemi presentano l'Architettura Lyric per un'ima ginee dettagliata e includono strumenti IA avanzati come SonoLyst per annotazioni e misurazioni automatiche durante gli esami anatomici delle 11-14 settimane. Tra i miglioramenti notevoli ci sono Graphicflow per la visualizzazione del flusso sanguigno e strumenti aggiornati come SonoPelvicFloor3.0, che riduce del 80% il tempo di esame delle misurazioni del pavimento pelvico, e SonoAVCfollicle2.0 per un miglioramento nella rilevazione dei follicoli.

Questo sviluppo risponde a una necessità critica in ambito sanitario, poiché circa 30.000 a 50.000 donne negli Stati Uniti vivono annualmente gravidanze complesse e ad alto rischio. I sistemi saranno presentati al SMFM 2025 Pregnancy Meeting a Denver.

GE HealthCare (GEHC) ha recibido la autorización 510(k) de la FDA para sus actualizados sistemas de ultrasonido Voluson Expert Series. La nueva serie, que comprende los modelos Voluson Expert 22, 20 y 18, combina imágenes de alta resolución con funciones impulsadas por IA y herramientas de automatización diseñadas para la salud de la mujer.

Los sistemas cuentan con la Arquitectura Lyric para imágenes detalladas e incluyen herramientas de IA mejoradas como SonoLyst para anotaciones y mediciones automatizadas durante exámenes anatómicos de 11-14 semanas. Las mejoras notables incluyen Graphicflow para la visualización del flujo sanguíneo y herramientas actualizadas como SonoPelvicFloor3.0, que reduce en un 80% el tiempo de examen de las mediciones del piso pélvico, y SonoAVCfollicle2.0 para mejorar la detección de folículos.

Este desarrollo aborda una necesidad crítica en el cuidado de la salud, ya que aproximadamente 30,000 a 50,000 mujeres en los Estados Unidos experimentan embarazos complejos y de alto riesgo anualmente. Los sistemas se exhibirán en la Reunión de Embarazo SMFM 2025 en Denver.

GE HealthCare (GEHC)는 업데이트된 Voluson Expert Series 초음파 시스템에 대해 FDA 510(k) 승인을 받았습니다. 새로운 시리즈는 Voluson Expert 22, 20 및 18 모델로 구성되어 있으며, 고해상도 이미징과 여성 건강을 위한 AI 기반 기능 및 자동화 도구를 결합합니다.

시스템은 상세 이미지를 위한 Lyric Architecture를 특징으로 하며, 11-14주 해부학적 검사 중 자동 주석 및 측정을 위한 SonoLyst와 같은 향상된 AI 도구를 포함합니다. 주목할 만한 개선 사항으로는 혈류 시각화를 위한 Graphicflow와 골반 바닥 측정 검사 시간을 80% 단축하는 SonoPelvicFloor3.0, 그리고 난포 검출 향상을 위한 SonoAVCfollicle2.0이 있습니다.

이 개발은 미국에서 매년 약 30,000~50,000명의 여성이 복잡하고 고위험 임신을 경험하는 중요한 의료 요구를 충족합니다. 이 시스템은 덴버에서 열리는 SMFM 2025 Pregnancy Meeting에서 전시될 예정입니다.

GE HealthCare (GEHC) a obtenu l'autorisation 510(k) de la FDA pour ses systèmes d'ultrason Voluson Expert Series mis à jour. La nouvelle série, composée des modèles Voluson Expert 22, 20 et 18, allie imagerie haute résolution à des fonctionnalités alimentées par l'IA et des outils d'automatisation conçus pour la santé des femmes.

Les systèmes sont dotés de l'Architecture Lyric pour une imagerie détaillée et incluent des outils d'IA améliorés tels que SonoLyst pour des annotations et des mesures automatisées lors des examens anatomiques de 11 à 14 semaines. Parmi les améliorations notables figurent Graphicflow pour la visualisation du flux sanguin et des outils mis à jour comme SonoPelvicFloor3.0, qui réduit de 80 % le temps des examens de mesure du plancher pelvien, et SonoAVCfollicle2.0 pour améliorer la détection des follicules.

Ce développement répond à un besoin critique en matière de santé, car environ 30 000 à 50 000 femmes aux États-Unis vivent chaque année des grossesses complexes et à haut risque. Les systèmes seront présentés lors de la réunion sur la grossesse SMFM 2025 à Denver.

GE HealthCare (GEHC) hat die FDA-Zulassung 510(k) für seine aktualisierten Voluson Expert Series Ultraschallsysteme erhalten. Die neue Serie, bestehend aus den Modellen Voluson Expert 22, 20 und 18, kombiniert hochauflösende Bildgebung mit KI-gestützten Funktionen und Automatisierungstools, die für die Gesundheitsversorgung von Frauen entwickelt wurden.

Die Systeme verfügen über die Lyric Architecture für eine detaillierte Bildgebung und umfassen verbesserte KI-Tools wie SonoLyst für automatisierte Anmerkungen und Messungen während anatomischer Untersuchungen in der 11.-14. Woche. Zu den bemerkenswerten Verbesserungen gehören Graphicflow zur Visualisierung des Blutflusses und aktualisierte Werkzeuge wie SonoPelvicFloor3.0, das die Zeit für Messungen des Beckenbodens um 80 % reduziert, sowie SonoAVCfollicle2.0 zur Verbesserung der Follikeldetektion.

Diese Entwicklung spricht ein kritisches Gesundheitsbedürfnis an, da jährlich etwa 30.000 bis 50.000 Frauen in den Vereinigten Staaten komplexe Hochrisiko-Schwangerschaften erleben. Die Systeme werden auf dem SMFM 2025 Pregnancy Meeting in Denver vorgestellt.

Positive
  • Received FDA 510(k) clearance for updated ultrasound systems
  • AI-powered features reduce exam time by 80% for pelvic floor measurements
  • Enhanced diagnostic capabilities for high-risk pregnancies
  • Improved accuracy and precision in follicle detection
Negative
  • None.

Insights

The FDA clearance of GE HealthCare's enhanced Voluson Expert Series marks a strategic advancement in the $9 billion global ultrasound market. The integration of AI capabilities directly addresses the growing challenges in managing high-risk pregnancies, which affect 30,000-50,000 women annually in the US alone.

Three key technological innovations stand out for their market implications: First, the SonoLyst AI suite's expansion to 11-14 week anatomical exams represents a critical advancement in early detection capabilities. Second, the 80% reduction in pelvic floor measurement exam time through SonoPelvicFloor3.0 offers substantial operational efficiency gains for healthcare providers. Third, the enhanced follicle detection accuracy with SonoAVCfollicle2.0 strengthens GE's position in the fertility clinic segment.

The timing of this release, coinciding with the SMFM 2025 Pregnancy Meeting, demonstrates strategic marketing execution and positions GE HealthCare to capture immediate market attention. The Lyric Architecture's improved imaging capabilities, particularly in difficult scanning conditions, addresses a important market need and could drive replacement cycles in existing installations.

For healthcare providers, the efficiency gains and improved diagnostic capabilities could translate to increased patient throughput and better clinical outcomes. This aligns with the broader industry trend toward AI-enabled workflow optimization and could support premium pricing in competitive bids.

  • Latest Voluson Expert 22, 20 and 18 ultrasound systems harness artificial intelligence and advanced tools and software for more efficient assessments
  • Voluson Expert Series delivers elevated performance, with focus on first trimester to reveal clearer anatomical details, aiding earlier detection and boosting diagnostic confidence

CHICAGO--(BUSINESS WIRE)-- GE HealthCare (Nasdaq: GEHC) today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the updated portfolio of Voluson™ Expert Series ultrasound systems. Voluson Expert 22, 20 and 18 combine high resolution image quality with advanced ultrasound technology and an ergonomic design for efficient workflow and a world-class user experience. The Voluson Expert Series integrates artificial intelligence (AI)-powered features and automation tools to help drive imaging performance and efficiencies in women’s healthcare.

Approximately 30,000 to 50,000 women in the United States experience complex, high-risk pregnancy each year.i When these complications are left undetected or untreated, it may harm the mother or the baby. The growing prevalence of these complicationsii underscores the need for innovative solutions that enable early detection and intervention.

The Voluson Expert Series, GE HealthCare’s most advanced women’s health ultrasound systems, offers premium ultrasound imaging for confident diagnoses for high risk, complex pregnancies. The Lyric Architecture is designed to unlock new imaging and processing power to deliver detailed and uniform images and reveal finer details within the anatomy with ease, even in difficult scanning conditions. AI-enabled functionality and automation tools are available to support faster assessments and early detection, diagnosis and intervention.

The SonoLyst suite of AI tools were designed to simplify exams through image recognition and automated annotations and measurements, increasing exam speed and accuracy. With this new release, clinicians can now utilize SonoLystlive during 11 to 14-week anatomical exams helping ensure required views are captured for diagnostic accuracy.  In addition, Voluson Expert Series ultrasound systems feature an expanded color Doppler offering, Graphicflow, which provides a graphical representation of the trajectories of the blood cells in real-time to visualize complex blood flow quickly and clearly, helping users differentiate normal from abnormal hemodynamics.

Voluson Expert Series also includes additional enhancements to select Voluson AI tools:

  • SonoPelvicFloor3.0 can help reduce pelvic floor measurement exam time by 80%.* This feature now expands anatomical views, and simplifies the exam process by automating plane alignment, live C-plane tracking, and measurements.
  • SonoAVCfollicle2.0 uses AI to increase accuracy and precision in follicle detection, resulting in a better success rate of detecting follicles, along with reduced artifacts and requiring less time for postprocessing.

These systems are compatible with a wide selection of unique specialty probes, including a new lightweight 2D/3D probe RAB7-D, and wireless Vscan Air™ dual probes.

“We are proud to introduce these updates to the Voluson Expert ultrasound systems, which represent our ongoing commitment to advancing technology that addresses women's health needs of today, and the future,” said Gerald Seifriedsberger, General Manager, Women’s Health, Advanced Visualization Solutions, GE HealthCare. “By introducing solutions that offer unparalleled clarity and detail, we can empower users with critical insights for informed care decisions and efficient exams, transforming how clinicians approach healthcare. Together, we can create a healthier future for all women.”

GE HealthCare will showcase the Voluson Expert series ultrasound systems at the Society for Maternal-Fetal Medicine (SMFM) 2025 Pregnancy Meeting™ taking place on January 27-February 1 in Denver. The Voluson Expert Series is available in the United States. For more information on the Voluson Expert Series, visit: https://www.gehealthcare.com/products/ultrasound/voluson.

*Versus manual exam

___________________________________

i Cleveland Clinic. High-Risk Pregnancy. Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/22190-high-risk-pregnancy. Last reviewed July 12, 2024. Accessed January 17, 2025.

ii Barfield WD, Besera G, Cox S, Warner L, Azeez O, Riggs J, Russell R, Bowron S, Churchill RE. From Data to Action: CDC's Public Health Surveillance for Women, Infants, and Children. 2nd ed. Centers for Disease Control and Prevention; 2020. https://www.cdc.gov/reproductive-health/media/pdfs/data-to-action/Data-To-Action_508.pdf. Accessed January 17, 2025.

 

Eric Tatro

Media Contact

GE HealthCare

+1 312 459 6140

Eric.Tatro@gehealthcare.com

Source: GE HealthCare

FAQ

What new features does GEHC's Voluson Expert Series include?

The series includes AI-powered features, Lyric Architecture for detailed imaging, SonoLyst for automated annotations, Graphicflow for blood flow visualization, and enhanced tools like SonoPelvicFloor3.0 and SonoAVCfollicle2.0.

How much time reduction does GEHC's SonoPelvicFloor3.0 achieve in exams?

SonoPelvicFloor3.0 reduces pelvic floor measurement exam time by 80% compared to manual exams.

When will GEHC showcase the new Voluson Expert Series?

GE HealthCare will showcase the systems at the Society for Maternal-Fetal Medicine (SMFM) 2025 Pregnancy Meeting in Denver, January 27-February 1.

What regulatory approval has GEHC received for the Voluson Expert Series?

GE HealthCare has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the updated portfolio.

What market need does GEHC's Voluson Expert Series address?

The systems address the needs of 30,000 to 50,000 women in the United States who experience complex, high-risk pregnancies annually.

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