GE HealthCare announces 510(k) submission for CleaRecon DL technology designed to improve image quality in the interventional suite with AI-based reconstruction
GE HealthCare (GEHC) has submitted a 510(k) application to the FDA for CleaRecon DL, an AI-based technology designed to enhance cone-beam computed tomography (CBCT) image quality in interventional procedures. The technology aims to remove image streaks and improve image interpretation confidence. To be available on Allia™ Image-Guided Solutions Systems, it represents GE HealthCare's commitment to advancing CBCT adoption. Additionally, the company is introducing OnWatch Predict, a predictive monitoring system for interventional image-guided systems designed to forecast component failures and reduce unplanned downtime.
GE HealthCare (GEHC) ha presentato una domanda 510(k) alla FDA per CleaRecon DL, una tecnologia basata sull'IA progettata per migliorare la qualità dell'immagine della tomografia computerizzata a fascio conico (CBCT) nelle procedure interventistiche. La tecnologia mira a rimuovere le striature delle immagini e a migliorare la fiducia nell'interpretazione delle immagini. Disponibile sui sistemi Allia™ Image-Guided Solutions, rappresenta l'impegno di GE HealthCare nell'accelerare l'adozione della CBCT. Inoltre, l'azienda sta introducendo OnWatch Predict, un sistema di monitoraggio predittivo per i sistemi di imaging interventistico progettato per prevedere i guasti dei componenti e ridurre i tempi di inattività non programmati.
GE HealthCare (GEHC) ha presentado una solicitud 510(k) a la FDA para CleaRecon DL, una tecnología basada en IA diseñada para mejorar la calidad de imagen de la tomografía computarizada con haz cónico (CBCT) en procedimientos intervencionistas. La tecnología busca eliminar las líneas en las imágenes y mejorar la confianza en la interpretación de las mismas. Estará disponible en los sistemas Allia™ Image-Guided Solutions, lo que representa el compromiso de GE HealthCare de avanzar en la adopción de CBCT. Además, la empresa está introduciendo OnWatch Predict, un sistema de monitoreo predictivo para sistemas de imagen guiada por intervención, diseñado para prever fallos en los componentes y reducir el tiempo de inactividad no planificado.
GE HealthCare (GEHC)는 FDA에 CleaRecon DL의 510(k) 신청을 제출했습니다. 이는 개입 절차에서 원추형 컴퓨터 단층촬영(CBCT) 이미지 품질을 향상시키기 위해 설계된 AI 기반 기술입니다. 이 기술은 이미지의 선명도를 제거하고 이미지 해석의 신뢰성을 향상시키는 것을 목표로 하고 있습니다. Allia™ 이미지 유도 솔루션 시스템에서 사용 가능하게 될 이 기술은 GE HealthCare가 CBCT 채택을 발전시키기 위한 의지를 보여줍니다. 또한, 회사는 부품 고장을 예측하고 계획되지 않은 다운타임을 줄이기 위해 설계된 개입 이미지 유도 시스템을 위한 예측 모니터링 시스템 OnWatch Predict를 도입하고 있습니다.
GE HealthCare (GEHC) a soumis une demande 510(k) à la FDA pour CleaRecon DL, une technologie basée sur l'IA conçue pour améliorer la qualité des images de tomographie par faisceau conique (CBCT) lors des procédures interventionnelles. La technologie vise à éliminer les stries d'image et à améliorer la confiance dans l'interprétation des images. Disponible sur les systèmes Allia™ Image-Guided Solutions, elle représente l'engagement de GE HealthCare à faire progresser l'adoption du CBCT. De plus, l'entreprise introduit OnWatch Predict, un système de surveillance prédictive pour les systèmes d'imagerie guidée par intervention conçu pour prévoir les pannes de composants et réduire les temps d'arrêt imprévus.
GE HealthCare (GEHC) hat einen 510(k)-Antrag bei der FDA für CleaRecon DL eingereicht, eine KI-basierte Technologie, die entwickelt wurde, um die Bildqualität der Cone-Beam-Computertomographie (CBCT) in interventionsmedizinischen Verfahren zu verbessern. Die Technologie zielt darauf ab, Bildstreifen zu entfernen und das Vertrauen in die Bildinterpretation zu erhöhen. Sie wird auf den Systemen von Allia™ Image-Guided Solutions verfügbar sein und stellt das Engagement von GE HealthCare dar, die CBCT-Übernahme voranzutreiben. Darüber hinaus führt das Unternehmen OnWatch Predict ein, ein prädiktives Überwachungssystem für interventionsbildgeführte Systeme, das darauf ausgelegt ist, Komponentenfehler vorherzusagen und ungeplante Ausfallzeiten zu reduzieren.
- Development of AI-based technology to improve CBCT image quality
- Expansion of product portfolio with OnWatch Predict system
- Strategic advancement in minimally invasive procedures market
- Product pending FDA 510(k) clearance and CE mark
- Not yet available for sale in US or EU markets
Insights
The submission of CleaRecon DL for FDA 510(k) clearance represents an incremental advancement in GE HealthCare's interventional imaging portfolio. The technology addresses a significant pain point in CBCT imaging - artifact reduction and image quality improvement - which could potentially expand the adoption of CBCT in clinical settings.
The key value proposition lies in the AI-based reconstruction capabilities that could enhance diagnostic confidence without introducing additional artifacts. Combined with the announcement of OnWatch Predict for predictive maintenance, this demonstrates GEHC's strategic focus on improving both clinical outcomes and operational efficiency.
However, market impact will be in the near term since:
- The technology is still pending regulatory approval
- It will only be available on Allia IGS Systems, limiting the addressable market
- Revenue impact will likely be gradual as healthcare facilities evaluate adoption
- CleaRecon DL* is designed to improve cone-beam computed tomography (CBCT) image quality by removing streaks and help clinicians improve their confidence in image interpretation when analyzing CBCT data
As demand for minimally invasive procedures continues to grow, GE HealthCare is committed to helping clinicians use image guidance technologies to their full potential by removing barriers with the goal of helping providers achieve better clinical and operational outcomes.
To be available on Allia™ Image-Guided Solutions (IGS) Systems, CleaRecon DL is designed to use AI-based reconstruction to improve image quality by removing streaks without introducing additional artifacts. It is also designed to improve CBCT analysis through clear images. This technology aims to advance the company’s vision to accelerate CBCT adoption in daily practice.
“GE HealthCare has been a leader in CBCT for more than two decades - offering continued innovation through offerings such as augmented guidance solutions designed to improve procedure outcomes, as well as developing a wide-bore platform capable of acquiring CBCT with obese patients, even with their arms down,” said Arnaud Marie, General Manager, Global Intervention at GE HealthCare. “Over the years, artifacts created in scans through natural movement of the body and the distribution of contrast have posed another significant challenge to clinicians when obtaining CBCT images - posing a major barrier to adoption of CBCT technology. We designed CleaRecon DL to address this challenge so physicians and their patients can benefit from this advanced imaging technology.”
In addition to CleaRecon DL, GE HealthCare is also introducing OnWatch Predict, predictive monitoring of interventional image-guided systems to provide enhanced service and increase system availability for on-time diagnosis, invasive procedures and treatments. Combining ongoing system diagnosis with user interface monitoring, image chain health and X-ray generation, OnWatch Predict is designed to forecast component failure, allowing clinicians to schedule service before an issue occurs with the system and limiting unplanned downtime.
For more information on GE HealthCare’s Allia IGS platform and the company’s commitment to advancing the practice of image guided therapy with artificial intelligence and digitization tools, visit GE HealthCare Booth #7330, RSNA 2024 press kit, or the RSNA 2024 events page.
*CleaRecon DL1,2
1) Designed to be used with Allia™ systems.
2) CleaRecon DL is an option using deep learning in 3DXR. 510(k) and CE mark pending. Not available for sale in US or EU.
About GE HealthCare Technologies Inc.
GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Advanced Visualization Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a
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Julie Allison
Senior Communications Manager
(347) 327-0836
julie.allison@gehealthcare.com
Source: GE HealthCare
FAQ
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