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Philips Spectral CT 7500 RT, world’s first spectral 4DCT respiratory-gated imaging receives FDA 510(k) clearance

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Philips has received FDA 510(k) clearance for its Spectral CT 7500 RT, the world's first spectral 4DCT respiratory-gated imaging system for radiation therapy. This innovative technology combines conventional and spectral CT capabilities in a single scan, enabling more precise radiation therapy planning by better visualizing tumor characteristics. The system reduces proton stopping-power ratio error by over 50% compared to conventional CT and creates stopping power ratio maps with less than 1% deviation, significantly improving treatment accuracy while sparing healthy tissue. This advancement allows for more personalized cancer treatment without adding extra steps to existing radiotherapy workflows.

Philips ha ricevuto l'approvazione 510(k) della FDA per il suo Spectral CT 7500 RT, il primo sistema al mondo di imaging respiratorio 4DCT a spettro per la terapia radiativa. Questa tecnologia innovativa combina capacità di CT convenzionali e spettroscopiche in un'unica scansione, consentendo una pianificazione della terapia radiativa più precisa attraverso una migliore visualizzazione delle caratteristiche del tumore. Il sistema riduce l'errore del rapporto di potenza di arresto dei protoni di oltre il 50% rispetto al CT convenzionale e crea mappe del rapporto di potenza di arresto con meno dell'1% di deviazione, migliorando significativamente l'accuratezza del trattamento risparmiando i tessuti sani. Questo progresso consente un trattamento del cancro più personalizzato senza aggiungere passaggi extra ai flussi di lavoro esistenti in radioterapia.

Philips ha recibido la autorización 510(k) de la FDA para su Spectral CT 7500 RT, el primer sistema de imagenología respiratoria 4DCT espectral del mundo para terapia de radiación. Esta tecnología innovadora combina capacidades de CT convencionales y espectrales en un solo escaneo, lo que permite una planificación de la terapia de radiación más precisa al visualizar mejor las características del tumor. El sistema reduce el error de la relación de potencia de detención de protones en más del 50% en comparación con el CT convencional y crea mapas de relación de potencia de detención con menos del 1% de desviación, mejorando significativamente la precisión del tratamiento mientras se protege el tejido sano. Este avance permite un tratamiento del cáncer más personalizado sin añadir pasos adicionales a los flujos de trabajo existentes de radioterapia.

Philips는 방사선 치료를 위한 세계 최초의 스펙트럼 4DCT 호흡 동기화 이미징 시스템인 Spectral CT 7500 RT에 대해 FDA 510(k) 승인을 받았습니다. 이 혁신적인 기술은 기존 CT 기능과 스펙트럼 CT 기능을 단일 스캔에 통합하여 종양 특성을 더 잘 시각화함으로써 방사선 치료 계획을 보다 정밀하게 합니다. 이 시스템은 기존 CT에 비해 양성자 정지 능력 비율 오류를 50% 이상 줄이고 1% 미만의 편차로 정지 능력 비율 맵을 생성하여 건강한 조직을 절약하면서 치료 정확성을 크게 향상시킵니다. 이 발전은 기존 방사선 치료 작업 흐름에 추가 단계를 추가하지 않고도 보다 맞춤형 암 치료를 가능하게 합니다.

Philips a reçu l'autorisation 510(k) de la FDA pour son Spectral CT 7500 RT, le premier système de radiothérapie par imagerie respiratoire 4DCT spectrale au monde. Cette technologie innovante combine des capacités de CT conventionnelles et spectrales dans un seul scan, permettant une planification de la thérapie par radiation plus précise grâce à une meilleure visualisation des caractéristiques tumorales. Le système réduit l'erreur du rapport de puissance d'arrêt des protons de plus de 50 % par rapport au CT conventionnel et crée des cartes de rapport de puissance d'arrêt avec moins de 1 % de déviation, améliorant ainsi considérablement l'exactitude du traitement tout en épargnant les tissus sains. Cette avancée permet un traitement du cancer plus personnalisé sans ajouter d'étapes supplémentaires aux flux de travail de radiothérapie existants.

Philips hat die FDA-Zulassung 510(k) für sein Spectral CT 7500 RT erhalten, das erste spektrale 4DCT-Atmungs-gesteuerte Bildgebungssystem für die Strahlentherapie weltweit. Diese innovative Technologie kombiniert die konventionellen und spektralen CT-Funktionen in einem einzigen Scan, wodurch eine präzisere Planung der Strahlentherapie ermöglicht wird, indem die Tumoreigenschaften besser visualisiert werden. Das System reduziert den Fehler des Protonen-Abbrechverhältnisses um über 50% im Vergleich zu konventionellem CT und erstellt Karten des Abbrechverhältnisses mit weniger als 1% Abweichung, was die Behandlungsgenauigkeit erheblich verbessert und gleichzeitig gesundes Gewebe schont. Dieser Fortschritt ermöglicht eine personalisierte Krebsbehandlung, ohne zusätzliche Schritte zu bestehenden Strahlentherapie-Workflows hinzuzufügen.

Positive
  • FDA 510(k) clearance received for innovative radiation therapy technology
  • 50% reduction in proton stopping-power ratio error compared to conventional CT
  • Less than 1% deviation in stopping power ratio maps
  • Cost reduction through elimination of additional scans
  • Seamless integration into existing clinical workflows
Negative
  • None.

Insights

The FDA clearance of Philips' Spectral CT 7500 RT represents a significant advancement in radiation therapy technology. The system's ability to combine conventional and spectral CT capabilities in a single scan, while offering respiratory-gated imaging, addresses key challenges in radiation oncology.

The technology's 50% reduction in proton stopping-power ratio error compared to conventional CT translates to improved treatment accuracy and better tissue preservation. This advancement could lead to reduced treatment complications and potentially better patient outcomes.

From a business perspective, this innovation strengthens Philips' position in the growing radiation oncology market. The system's workflow integration and cost reduction benefits make it an attractive option for healthcare providers, potentially driving adoption and revenue growth. This could positively impact Philips' medical imaging division, which is a core revenue generator for the company.

November 12, 2024

Designed specifically for use in radiation oncology, new Spectral CT 7500 RT enables personalized radiation therapy planning to deliver better care for more cancer patients

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced a major advance in radiation oncology with 510(k) clearance from the US Food and Drug Administration (FDA) for its new detector-based spectral computed tomography (CT) radiotherapy solution. Philips Spectral CT 7500 RT marks the next step in personalized cancer care by integrating the unique tumor visualization and tissue characterization capabilities of spectral CT into cancer treatment and planning. Radiation oncologists can now precisely target radiation therapy to the specific physiological characteristics of a patient's tumor, minimizing damage to healthy surrounding tissue and reducing potential unwanted side effects.

Spectral CT 7500 RT revolutionizes radiation oncology imaging by combining true conventional and spectral CT capabilities in a single scan, seamlessly integrating into existing clinical workflows. As the first radiation therapy CT scanner to offer respiratory-gated spectral imaging, radiation oncologists have all the benefits of 4D conventional CT, and can also now apply the improved visualization and quantification of spectral CT. This latest innovation from Philips benefits radiotherapy departments by reducing the costs of additional scans while enhancing accuracy and enabling more effective treatment plans for a greater number of cancer patients.

“Tumor delineation, beam attenuation, and respiratory motion are critical factors in radiotherapy planning. The spectral information provided by Spectral CT 7500 RT enhances tissue characterization, enabling wider access to highly personalized and precisely targeted treatment for more patients without adding extra steps to current radiotherapy workflows,” said Dan Xu, Global Business Leader of CT at Philips.

Spectral CT has been shown to reduce proton stopping-power ratio (SPR) error by more than 50% compared to conventional CT, improving the accuracy of radiation treatment and sparing healthy tissue [1]. Philips Spectral CT 7500 RT acquires both true conventional CT and spectral CT information in a single scan. It can automatically create the SPR map and direct electron density (ED) results with less than 1% deviation [1] to enhance both the dose calculation and accuracy of radiotherapy planning.

"The Spectral CT system provides us with several capabilities that conventional CT does not have. It can provide electron density and effective atomic number results, which we can convert to the proton stopping-power ratio. And published data shows that the stopping power ratio obtained in this way has fewer uncertainties compared to regular calibration curves, thereby reducing the uncertainty margins during treatment planning," said Dr. Zhong Su, Physics Director, Department of Radiation Oncology at the University of Arkansas for Medical Sciences (UAMS) Medical Center (Arkansas, USA).

Philips CT has revolutionized medical imaging over the past four decades, helping physicians make confident and precise diagnoses to deliver better care for more people. The company is a recognized leader in spectral CT with its ‘always-on’ detector-based technology, providing spectral CT solutions across a wide range of clinical areas including cardiology, oncology, neurology, musculoskeletal, and pediatrics. For more information, visit Philips at RSNA 2024.

[1] Longarino FK, Kowalewski A, Tessonnier T, et al. Potential of a Second-Generation Dual-Layer Spectral CT for Dose Calculation in Particle Therapy Treatment Planning. Front Oncol. 2022;12. doi:10.3389/fonc.2022.853495

For further information, please contact:

Kathy O’Reilly
Philips Global External Relations
Tel.: +1 978-221-8919
E-mail: kathy.oreilly@philips.com

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring, and enterprise informatics, as well as in personal health. Philips generated 2023 sales of EUR 18.2 billion and employs approximately 69,300 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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FAQ

What FDA clearance did Philips (PHG) receive in November 2024?

Philips received FDA 510(k) clearance for its Spectral CT 7500 RT, the world's first spectral 4DCT respiratory-gated imaging system for radiation therapy.

How much does the Philips (PHG) Spectral CT 7500 RT improve treatment accuracy?

The system reduces proton stopping-power ratio error by more than 50% compared to conventional CT and creates stopping power ratio maps with less than 1% deviation.

What are the key benefits of Philips (PHG) Spectral CT 7500 RT for radiotherapy departments?

The system reduces costs by eliminating additional scans, enhances accuracy in treatment planning, and enables more effective treatment plans while seamlessly integrating into existing workflows.

How does Philips (PHG) Spectral CT 7500 RT improve cancer treatment?

It enables more precise targeting of radiation therapy based on specific tumor characteristics while minimizing damage to surrounding healthy tissue, allowing for more personalized cancer treatment.

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