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Cosmo Intelligent Medical Devices Unveils Next Generation GI Genius(TM) Hardware with New FDA Clearance

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Cosmo Intelligent Medical Devices (Cosmo IMD), a division of Cosmo Pharmaceuticals, has received FDA 510(k) clearance for its next-generation GI Genius™ hardware. This sixth-generation device, exclusively distributed by Medtronic globally, represents a significant advancement in AI-enhanced endoscopy. Key features include:

1. Enhanced AI capabilities
2. Versatile AI app integration
3. Improved connectivity
4. Energy efficiency
5. Reliable performance

The hardware incorporates the FDA-cleared ColonPRO™ software, designed to assist endoscopists in identifying potential polyps during colorectal cancer screenings. Utilizing NVIDIA IGX Orin™ and NVIDIA Holoscan™ technologies, the GI Genius™ system aims to elevate physician performance and standardize quality metric reporting in healthcare.

Cosmo Intelligent Medical Devices (Cosmo IMD), una divisione di Cosmo Pharmaceuticals, ha ricevuto l' per il suo hardware di nuova generazione GI Genius™. Questo dispositivo di sesta generazione, distribuito esclusivamente da Medtronic a livello globale, rappresenta un progresso significativo nell'endoscopia potenziata dall'IA. Le caratteristiche principali includono:

1. Capacità AI avanzate
2. Integrazione versatile delle app AI
3. Migliore connettività
4. Efficienza energetica
5. Prestazioni affidabili

L'hardware incorpora il software ColonPRO™ approvato dalla FDA, progettato per assistire gli endoscopisti nell'identificazione di potenziali polipi durante gli screening per il cancro colorettale. Utilizzando le tecnologie NVIDIA IGX Orin™ e NVIDIA Holoscan™, il sistema GI Genius™ mira a migliorare le prestazioni dei medici e a standardizzare la reportistica dei parametri di qualità nel settore sanitario.

Cosmo Intelligent Medical Devices (Cosmo IMD), una división de Cosmo Pharmaceuticals, ha recibido la para su hardware de próxima generación GI Genius™. Este dispositivo de sexta generación, distribuido exclusivamente por Medtronic a nivel mundial, representa un avance significativo en la endoscopia mejorada por IA. Las características clave incluyen:

1. Capacidades de IA mejoradas
2. Integración versátil de aplicaciones de IA
3. Conectividad mejorada
4. Eficiencia energética
5. Rendimiento confiable

El hardware incorpora el software ColonPRO™ aprobado por la FDA, diseñado para ayudar a los endoscopistas a identificar pólipos potenciales durante los exámenes de detección de cáncer colorrectal. Utilizando tecnologías NVIDIA IGX Orin™ y NVIDIA Holoscan™, el sistema GI Genius™ tiene como objetivo elevar el rendimiento de los médicos y estandarizar la presentación de informes de métricas de calidad en el cuidado de la salud.

코스모 인텔리전트 메디컬 디바이스(Cosmo IMD), 코스모 제약의 한 부서가 차세대 GI Genius™ 하드웨어에 대해 FDA 510(k) 승인을 받았습니다. 이 6세대 장치는 Medtronic에 의해 전 세계적으로 독점 배포되며, AI 강화 내시경 분야에서 중요한 발전을 나타냅니다. 주요 특징은 다음과 같습니다:

1. 향상된 AI 기능
2. 다기능 AI 앱 통합
3. 개선된 연결성
4. 에너지 효율성
5. 신뢰할 수 있는 성능

이 하드웨어는 FDA 승인된 ColonPRO™ 소프트웨어를 포함하고 있으며, 이는 내시경 의사가 대장암 검진 중 잠재적인 폴립을 식별하는 데 도움을 주도록 설계되었습니다. NVIDIA IGX Orin™ 및 NVIDIA Holoscan™ 기술을 활용하여 GI Genius™ 시스템은 의사의 성능을 향상시키고 의료에서 품질 지표 보고를 표준화하는 것을 목표로 합니다.

Cosmo Intelligent Medical Devices (Cosmo IMD), une division de Cosmo Pharmaceuticals, a obtenu l' pour son matériel de nouvelle génération GI Genius™. Ce dispositif de sixième génération, distribué exclusivement par Medtronic à l'échelle mondiale, représente une avancée significative dans l'endoscopie améliorée par l'IA. Les caractéristiques clés incluent :

1. Capacités d'IA améliorées
2. Intégration d'applications IA polyvalentes
3. Connectivité améliorée
4. Efficacité énergétique
5. Performance fiable

Le matériel intègre le logiciel ColonPRO™ approuvé par la FDA, conçu pour aider les endoscopistes à identifier les polypes potentiels lors des dépistages du cancer colorectal. En utilisant les technologies NVIDIA IGX Orin™ et NVIDIA Holoscan™, le système GI Genius™ vise à améliorer les performances des médecins et à standardiser le reporting des indicateurs de qualité dans le secteur de la santé.

Cosmo Intelligent Medical Devices (Cosmo IMD), eine Abteilung von Cosmo Pharmaceuticals, hat die FDA 510(k)-Genehmigung für seine nächste Generation des GI Genius™-Hardware erhalten. Dieses Gerät der sechsten Generation, das weltweit ausschließlich von Medtronic vertrieben wird, stellt einen bedeutenden Fortschritt in der AI-unterstützten Endoskopie dar. Zu den wichtigsten Funktionen gehören:

1. Verbesserte KI-Fähigkeiten
2. Vielseitige KI-App-Integration
3. Verbesserte Konnektivität
4. Energieeffizienz
5. Zuverlässige Leistung

Die Hardware umfasst die von der FDA genehmigte ColonPRO™-Software, die Endoskopikern helfen soll, potenzielle Polypen während der Darmkrebsvorsorgeuntersuchungen zu identifizieren. Durch die Nutzung der Technologien NVIDIA IGX Orin™ und NVIDIA Holoscan™ zielt das GI Genius™-System darauf ab, die Leistung der Ärzte zu steigern und die Berichterstattung über Qualitätskennzahlen im Gesundheitswesen zu standardisieren.

Positive
  • FDA 510(k) clearance received for next-generation GI Genius™ hardware
  • Enhanced AI capabilities and versatile AI app integration
  • Improved connectivity for potential seamless integration within healthcare systems
  • Energy-efficient design for quiet and environmentally friendly operation
  • Incorporation of advanced NVIDIA technologies for real-time performance
Negative
  • None.

Dublin, Ireland--(Newsfile Corp. - July 31, 2024) - Cosmo Intelligent Medical Devices (Cosmo IMD), a division of Cosmo Pharmaceuticals N.V. (SIX: COPN) (FSE: C43) (“Cosmo”) focused on pioneering medical devices powered by Artificial Intelligence, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the next generation GI Genius™ hardware, the latest development of the GI Genius™ intelligent endoscopy system, which Medtronic exclusively distributes globally. This milestone reaffirms the GI Genius™ platform’s leadership in AI-enhanced endoscopy and marks a significant advancement in the realm of medical technology.

The GI Genius™ hardware, now in its sixth generation, is engineered to elevate physician performance with sophisticated AI-driven insights during patient procedures. This latest iteration includes the FDA-cleared ColonPRO™ software, the GI Genius™ AI colon application designed to help endoscopists identify potential polyps and standardize quality metric reporting during colorectal cancer screenings.

Revolutionary features of the latest GI Genius™ hardware:

  • Enhanced AI Capabilities: The module extends the platform’s ability to support innovations in AI and enables acceleration towards exciting new AI features.
  • Versatile AI App Integration: The module is capable of hosting multiple AI apps, significantly broadening the platform’s utility, through a developer program led by Cosmo IMD with Medtronic’s[1] commercial leadership. See link.
  • Improved Connectivity: With additional interconnectivity options, the GI Genius™ hardware potentially integrates seamlessly within the healthcare system to standardize quality metrics and procedure highlights.
  • Energy Efficiency: The innovative design of the module achieves more with less energy, ensuring a quiet, efficient, and environmentally friendly operation.
  • Reliable Performance: It integrates hardware technologies to support real-time performance during medical procedures and an extended product lifecycle.

These advancements were realized through Cosmo IMD’s meticulous engineering, utilizing state-of-the-art components such as NVIDIA IGX Orin™ and NVIDIA Holoscan™ technologies.

The GI Genius™ hardware represents a new frontier in endoscopic technology, providing healthcare professionals with continuously evolving AI capabilities to enhance patient care. This advancement underscores Cosmo Intelligent Medical Devices’ commitment to staying at the forefront of innovation and excellence in healthcare.

Nhan Ngo Dinh, President of Cosmo Intelligent Medical Devices commented:The GI Genius™ system sets a new standard in endoscopic technology. Our continuous innovation is driven by a commitment to enhancing patient care through AI. This FDA clearance marks a significant achievement, reinforcing our leadership in the field and our dedication to providing physicians with the tools they need to deliver exceptional medical outcomes.

About Cosmo

Cosmo is a pharmaceutical company focused on developing and commercializing products to treat selected gastrointestinal disorders, to improve endoscopy quality measures through aiding the detection of colonic lesions, and to treat selected dermatological conditions. Cosmo develops and manufactures products which are distributed globally by selected partners including Lialda®/Mezavant®/Mesavancol®, Uceris®/Cortiment®, Aemcolo®/ Relafalk®, Lumeblue® and Winlevi®. Cosmo has also developed medical devices for endoscopy and has a partnership with Medtronic for the global distribution of GI Genius™ which uses artificial intelligence to help detect potential signs of colon cancer. The company also has a rich development pipeline. For additional information on Cosmo and its products please visit the Company’s website: www.cosmopharma.com.

Upcoming Calendar of Events

H.C. Wainwright Global Investment Conference, N.Y.: September 9-11, 2024

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Contact

Hazel Winchester

Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: +353 1 817 03 70

hwinchester@cosmopharma.com


[1]Existing GI GeniusTM hardware can also be upgraded to host multiple independent AI applications. More communication with current customers will be forthcoming.

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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/218356

FAQ

What is the latest FDA clearance for Cosmo Intelligent Medical Devices (CMOPF)?

Cosmo Intelligent Medical Devices has received FDA 510(k) clearance for its next-generation GI Genius™ hardware, which is the sixth generation of the AI-enhanced endoscopy system.

What are the key features of the new GI Genius™ hardware?

The key features include enhanced AI capabilities, versatile AI app integration, improved connectivity, energy efficiency, and reliable performance for real-time medical procedures.

How does the GI Genius™ system assist in colorectal cancer screenings?

The GI Genius™ system incorporates the FDA-cleared ColonPRO™ software, which helps endoscopists identify potential polyps and standardize quality metric reporting during colorectal cancer screenings.

Who is the global distributor of the GI Genius™ system?

Medtronic is the exclusive global distributor of the GI Genius™ intelligent endoscopy system.

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