Inspira™ Introduces Advanced Features for INSPIRA™ ART100, Further Amplifying User and System Support
Inspira Technologies (Nasdaq: IINN) has announced new support features for its FDA-cleared INSPIRA™ ART100 system, enhancing medical team procedures and efficiency in extracorporeal life support technology. The updates include integration with hospital procedures, system-activated alarm troubleshooting, and advanced software display features for complex care situations.
The ART100 system adds oxygen to blood and removes carbon dioxide, functioning as a heart-lung support for critical care patients. Key features include a compact design, four-hour emergency uptime, and compatibility with various disposable equipment. The system received FDA 510(k) clearance for CBP procedures and Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures in May and July 2024.
Inspira Technologies (Nasdaq: IINN) ha annunciato nuove funzionalità di supporto per il suo sistema INSPIRA™ ART100 approvato dalla FDA, migliorando le procedure e l'efficienza del team medico nella tecnologia di supporto vitale extracorporeo. Gli aggiornamenti includono integrazione con le procedure ospedaliere, risoluzione dei problemi degli allarmi attivati dal sistema e funzionalità avanzate di visualizzazione software per situazioni di cura complesse.
Il sistema ART100 aggiunge ossigeno al sangue e rimuove anidride carbonica, funzionando come supporto cardiopolmonare per pazienti in condizioni critiche. Le caratteristiche chiave includono un design compatto, quattro ore di operatività di emergenza e compatibilità con vari dispositivi usa e getta. Il sistema ha ricevuto l'approvazione 510(k) della FDA per le procedure di CBP e la certificazione AMAR israeliana per sia l'ossigenazione extracorporea a membrana che per le procedure di bypass cardiopolmonare a maggio e luglio 2024.
Inspira Technologies (Nasdaq: IINN) ha anunciado nuevas funciones de soporte para su sistema INSPIRA™ ART100 aprobado por la FDA, mejorando los procedimientos y la eficiencia del equipo médico en la tecnología de soporte vital extracorpóreo. Las actualizaciones incluyen la integración con los procedimientos hospitalarios, la solución de problemas de alarmas activadas por el sistema y funciones avanzadas de visualización de software para situaciones complejas de atención.
El sistema ART100 agrega oxígeno a la sangre y elimina el dióxido de carbono, funcionando como soporte cardiopulmonar para pacientes en estado crítico. Las características clave incluyen un diseño compacto, cuatro horas de funcionamiento de emergencia y compatibilidad con varios equipos desechables. El sistema recibió la autorización 510(k) de la FDA para procedimientos de CBP y la certificación AMAR israelí para tanto la oxigenación por membrana extracorpórea como para procedimientos de bypass cardiopulmonar en mayo y julio de 2024.
Inspira Technologies (Nasdaq: IINN)은 FDA 승인 INSPIRA™ ART100 시스템의 새로운 지원 기능을 발표하였으며, 이는 체외 생명 유지 기술에서 의료 팀의 절차와 효율성을 향상시킬 수 있습니다. 업데이트에는 병원 절차와의 통합, 시스템 활성화 알람 문제 해결, 복잡한 치료 상황을 위한 고급 소프트웨어 디스플레이 기능이 포함됩니다.
ART100 시스템은 혈액에 산소를 추가하고 이산화탄소를 제거하여, 중환자에 대한 심장-폐 지원 역할을 합니다. 주요 특징으로는 컴팩트한 디자인, 4시간 비상 가동 시간, 다양한 일회용 장비와의 호환성이 있습니다. 이 시스템은 2024년 5월과 7월에 CBP 절차에 대한 FDA 510(k) 승인을 받았고, 이스라엘 AMAR 인증을 받아 체외막 산소화 및 심장폄 바이패스 절차 모두를 지원합니다.
Inspira Technologies (Nasdaq: IINN) a annoncé de nouvelles fonctionnalités de support pour son système INSPIRA™ ART100 approuvé par la FDA, améliorant les procédures et l'efficacité de l'équipe médicale dans la technologie de soutien vital extracorporel. Les mises à jour comprennent l'intégration avec les procédures hospitalières, le dépannage des alarmes activées par le système et des fonctionnalités avancées d'affichage logiciel pour des situations de soins complexes.
Le système ART100 ajoute de l'oxygène au sang et élimine le dioxyde de carbone, agissant comme un soutien cardiopulmonaire pour les patients en soins critiques. Les caractéristiques clés comprennent un design compact, une autonomie d'urgence de quatre heures et une compatibilité avec divers équipements jetables. Le système a reçu l'autorisation 510(k) de la FDA pour les procédures de CBP et la certification AMAR israélienne pour l'oxygénation par membrane extracorporelle ainsi que pour les procédures de pontage cardiopulmonaire en mai et juillet 2024.
Inspira Technologies (Nasdaq: IINN) hat neue Unterstützungsfunktionen für sein FDA-zugelassenes INSPIRA™ ART100 System angekündigt, die die Verfahren und Effizienz des medizinischen Teams in der extrakorporalen Lebensunterstützungstechnologie verbessern. Zu den Updates gehören die Integration in Krankenhausverfahren, die Fehlersuche bei systemaktivierten Alarmen und erweiterte Softwareanzeigefunktionen für komplexe Pflegesituationen.
Das ART100-System fügt dem Blut Sauerstoff hinzu und entfernt Kohlendioxid und fungiert als Herz-Lungen-Unterstützung für kritisch kranke Patienten. Zu den wichtigsten Merkmalen gehören ein kompaktes Design, eine Notfallbetriebszeit von vier Stunden und die Kompatibilität mit verschiedenen Einweggeräten. Das System erhielt im Mai und Juli 2024 die FDA 510(k) Genehmigung für CBP-Verfahren und die israelische AMAR-Zertifizierung sowohl für die extrakorporale Membranoxygenierung als auch für die kardiopulmonale Bypassverfahren.
- FDA 510(k) clearance obtained for INSPIRA ART100
- Israeli AMAR certification received for multiple procedures
- System provides 4-hour emergency uptime capability
- Compatible with various market-available disposable equipment
- Other key products still in development phase without regulatory approval
- Operating in highly competitive $19B mechanical ventilation market
Insights
The introduction of advanced features for the INSPIRA ART100 system represents a strategic move in Inspira's product evolution, particularly following its recent FDA 510(k) clearance and Israeli AMAR certification. The enhancements address three critical areas in acute care settings:
- Integration with hospital procedures and safety practices, reducing implementation barriers
- Advanced alarm troubleshooting systems, important for high-stress scenarios
- Improved visual information display for isolated or in-transit patient care
These updates align with the broader industry trend toward more intuitive medical devices, as healthcare facilities face persistent staffing challenges and increasing patient loads. The timing is particularly relevant given the recent regulatory approvals, as it demonstrates continued product development momentum and responsiveness to user feedback.
The market implications are nuanced. While these features may not directly drive significant new sales, they could accelerate adoption rates among existing customers and reduce training overhead, particularly important for a novel technology entering the established
The development of the HYLA blood sensor and real-time monitoring capabilities positions INSPIRA ART100 as a comprehensive platform rather than just a device, potentially creating stronger competitive barriers and higher switching costs for customers. This platform approach, combined with the recent regulatory approvals and feature enhancements, could strengthen Inspira's position in negotiations with potential distribution partners and healthcare systems.
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The new features provide valuable resources for clinical teams using the system within its intent of use. For example, the system is designed to integrate a given hospital's established procedures and safety practices and includes system-activated alarm troubleshooting uniquely designed to provide valuable direction when time is of the essence and user anxiety is running high. The system also provides a prominent screen with advanced software that displays information in an accessible and visible manner during complicated and challenging care situations – for example when the patient is isolated or in-transit.
These new features are intended to further support staff using the INSPIRA ART100's existing advanced and cutting-edge software already designed to navigate the staff through a step-by-step setup process, demonstrating another example of Inspira's dedication through innovation to assist medical teams to manage complex medical procedures more effectively.
"Our goal is to develop systems that support medical professionals in their work to treat patients and save lives", said Dagi Ben-Noon, Chief Executive Officer of Inspira. "These additions reflect our commitment to being pioneers in the life support sector."
The INSPIRA ART100 system utilizes a technique that adds oxygen to the blood and removes carbon dioxide, with the enriched blood being circulated back to the patient, taking over the functionality of the heart and/or lungs in critical care patients. The INSPIRA ART100 has a small footprint design, provides up to four hours of uptime in emergency scenarios, and can be used with various types of disposable equipment available on the market.
Inspira™ Technologies OXY B.H.N. Ltd.
Inspira Technologies is an innovative medical technology company targeting to better the life support and respiratory treatment arena. The Company is developing a breakthrough Augmented Respiration Technology (INSPIRA™ ART), a groundbreaking device poised to revolutionize and potentially replace the
In May and July 2024, respectively, the Company's INSPIRA™ ART100 system has obtained FDA 510(k) clearance for use in CBP procedures, along with the Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.
The Company's other products and technologies, including the INSPIRA ART also known as the INSPIRA™ ART500 or Gen 2, the INSPIRA™ Cardi-ART portable modular device, VORTX™ Oxygen Delivery System, and HYLA™ blood sensor, are currently being designed and developed, and have not yet been tested or used in humans nor approved by any regulatory entity.
For more information, please visit our corporate website at https://inspira-technologies.com
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This press release contains express or implied forward-looking statements pursuant to
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SOURCE Inspira Technologies
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