Inspira Technologies Showcases FDA-Cleared ART100 System
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
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Should l Buy IINN?
Source: Newsfilter
- Strategic Showcase: Inspira Technologies will present its FDA-cleared INSPIRA™ ART100 system at the AmSECT International Conference from March 25-29, 2026, in Austin, Texas, aiming to engage clinical decision-makers who influence hospital purchasing decisions and enhance market visibility.
- Leveraging FDA Approval: The ART100 system, which received FDA 510(k) clearance in May 2024, will be showcased to validate its readiness for clinical integration in cardiopulmonary bypass procedures, thereby accelerating market penetration.
- Active Distribution Channel: The collaboration with Glo-Med Networks Inc. for the presentation demonstrates Inspira's active commercial pipeline, marking a transition from development to sales execution and market visibility, enhancing its competitive position.
- Key Phase in Commercial Strategy: Global VP Sales Mike Hershkovitz noted that this event represents a critical phase in the company's U.S. commercial strategy, aimed at expanding clinical partnerships and distribution footprint to drive rapid market share growth.
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About IINN
Inspira Technologies Oxy B.H.N Ltd, formerly Insense Medical Ltd, incorporated on February 27, 2018, is a specialty medical device company based in Israel. The Company is engaged in the research, development, manufacture, and marketing of respiratory support technology that is intended to provide an alternative to invasive mechanical ventilation (MV). It provides patients with acute respiratory distress syndrome to maintain spontaneous breathing and avoid the various risks associated with the use of MV.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Inspira Technologies Deploys ART100 System at Leading U.S. Hospital
- Market Expansion: Inspira Technologies has deployed its FDA-cleared INSPIRA™ ART100 system at a leading U.S. academic medical center, further expanding its presence in the Tier-1 hospital market, which is expected to enhance the company's market share in the medical device sector.
- Clinical Evaluation Initiation: The ART100 system has been integrated into the center's clinical workflow to support a structured evaluation aimed at defining clinical protocols and facilitating broader institutional adoption, paving the way for future commercialization.
- Strategic Execution: Mike Hershkovitz, Global VP Sales, stated that this deployment represents a continued execution of the company's U.S. commercial strategy, demonstrating that the ART100 meets the operational and clinical demands of top-tier healthcare providers, thereby strengthening the company's competitive position in the industry.
- Future Development Potential: Inspira Technologies is advancing the development of the next-generation INSPIRA ART500 system, designed to provide oxygenation support while patients remain awake, further solidifying its market position within the life-support and MedTech landscape.
See More
Inspira Technologies Showcases FDA-Cleared ART100 System
- Strategic Showcase: Inspira Technologies will present its FDA-cleared INSPIRA™ ART100 system at the AmSECT International Conference from March 25-29, 2026, in Austin, Texas, aiming to engage clinical decision-makers who influence hospital purchasing decisions and enhance market visibility.
- Leveraging FDA Approval: The ART100 system, which received FDA 510(k) clearance in May 2024, will be showcased to validate its readiness for clinical integration in cardiopulmonary bypass procedures, thereby accelerating market penetration.
- Active Distribution Channel: The collaboration with Glo-Med Networks Inc. for the presentation demonstrates Inspira's active commercial pipeline, marking a transition from development to sales execution and market visibility, enhancing its competitive position.
- Key Phase in Commercial Strategy: Global VP Sales Mike Hershkovitz noted that this event represents a critical phase in the company's U.S. commercial strategy, aimed at expanding clinical partnerships and distribution footprint to drive rapid market share growth.
See More
Inspira Technologies Secures Major Procurement Approval
- Stock Surge: Inspira Technologies OXY (IINN) shares surged over 28% in pre-market trading on Monday, reflecting strong market interest and heightened investor confidence in the company's new product.
- Procurement Approval: Israel's largest health services provider, Clalit Health Services, approved the procurement of Inspira's FDA-cleared ART100 platform, marking a significant milestone in the medical device sector for the company.
- Market Reach: The ART100 system will be rapidly deployed across Clalit’s healthcare network, which serves approximately 4.9 million members, indicating a swift expansion of the company's market share and enhanced brand presence.
- Clinical Validation: The approval of ART100 represents not only a successful regulatory clearance but also strong clinical validation for its application in cardiopulmonary bypass and ECMO procedures, signaling substantial future commercial growth potential.
See More
Inspira Technologies Secures Clalit Approval for ART100 System
- Commercial Activation: Inspira Technologies' INSPIRA™ ART100 system has received approval from Clalit Health Services, marking its transition to commercial availability within a network serving approximately 4.9 million members, which is expected to significantly enhance the company's competitiveness in the medical device market.
- Network Scale: Clalit operates 14 major hospitals and over 1,600 clinics, and this approval allows the ART100 to penetrate one of the most sophisticated healthcare supply chains globally, further solidifying Inspira's market position in high-end medical devices.
- Clinical Value Validation: Following a rigorous technical and clinical review, the ART100's safety and efficacy have been strongly validated, providing a powerful reference case for Inspira's promotion in other global health systems and enhancing its market credibility.
- Long-Term Revenue Foundation: CEO Dagi Ben-Noon stated that this approval lays the groundwork for potentially long-term, high-quality revenue, and is expected to accelerate the company's commercialization efforts in the U.S. and other global markets.
See More
Inspira Technologies Validates HYLA System for Heart-Lung Surgery Market
- Market Penetration Opportunity: Inspira Technologies has successfully validated its HYLA™ system, which is expected to rapidly enter the approximately $50 billion heart-lung surgery market, marking a strategic expansion for the company in the medical device sector.
- Technical Performance Breakthrough: The HYLA™ system demonstrated a 94.2% accuracy in pCO₂ measurement during advanced lab testing, aligning with clinical needs and enabling real-time patient monitoring, thereby reducing complications during heart-lung machine and ECMO procedures.
- Standalone System Advantage: By decoupling the sensor from life-support hardware, the HYLA™ system achieves universal compatibility with existing operating room or ICU workflows, significantly expanding the company's total addressable market and activating a high-margin recurring revenue model.
- Future Development Strategy: The company plans to submit a regulatory application to the FDA in 2026, with CEO Dagi Ben-Noon stating that offering HYLA as a standalone solution will accelerate market entry and meet the substantial global demand for perfusion systems.
See More
Inspira Technologies Achieves Major Milestone in U.S. Hospital
- Clinical Evaluation Completed: Inspira's INSPIRA™ ART100 system has completed its clinical evaluation at a leading U.S. academic medical center, successfully treating approximately 30 patients, marking its transition from pilot use to standard clinical workflow and significantly enhancing the company's recognition in the medical device market.
- Procurement Process Initiated: The medical center has initiated an internal procurement process for multiple ART100 systems, indicating that the technology's clinical value and reliability have been thoroughly validated, which is expected to drive broader adoption of ART100 across other healthcare institutions.
- Technology Validation: The ART100 system is the first to progress from clinical evaluation to a budgeted procurement pathway at a major U.S. academic medical center, reflecting Inspira's competitiveness and market potential in the medical device sector, thereby strengthening its commercial positioning.
- Future Development Outlook: Inspira CEO Dagi Ben-Noon stated that this milestone will facilitate the broader adoption of the ART100 platform across leading healthcare institutions, further solidifying the company's market position in life support and MedTech.
See More
Inspira Technologies Deploys ART100 System at Leading U.S. Hospital
- Market Expansion: Inspira Technologies has deployed its FDA-cleared INSPIRA™ ART100 system at a leading U.S. academic medical center, further expanding its presence in the Tier-1 hospital market, which is expected to enhance the company's market share in the medical device sector.
- Clinical Evaluation Initiation: The ART100 system has been integrated into the center's clinical workflow to support a structured evaluation aimed at defining clinical protocols and facilitating broader institutional adoption, paving the way for future commercialization.
- Strategic Execution: Mike Hershkovitz, Global VP Sales, stated that this deployment represents a continued execution of the company's U.S. commercial strategy, demonstrating that the ART100 meets the operational and clinical demands of top-tier healthcare providers, thereby strengthening the company's competitive position in the industry.
- Future Development Potential: Inspira Technologies is advancing the development of the next-generation INSPIRA ART500 system, designed to provide oxygenation support while patients remain awake, further solidifying its market position within the life-support and MedTech landscape.
See More
Inspira Technologies Showcases FDA-Cleared ART100 System
- Strategic Showcase: Inspira Technologies will present its FDA-cleared INSPIRA™ ART100 system at the AmSECT International Conference from March 25-29, 2026, in Austin, Texas, aiming to engage clinical decision-makers who influence hospital purchasing decisions and enhance market visibility.
- Leveraging FDA Approval: The ART100 system, which received FDA 510(k) clearance in May 2024, will be showcased to validate its readiness for clinical integration in cardiopulmonary bypass procedures, thereby accelerating market penetration.
- Active Distribution Channel: The collaboration with Glo-Med Networks Inc. for the presentation demonstrates Inspira's active commercial pipeline, marking a transition from development to sales execution and market visibility, enhancing its competitive position.
- Key Phase in Commercial Strategy: Global VP Sales Mike Hershkovitz noted that this event represents a critical phase in the company's U.S. commercial strategy, aimed at expanding clinical partnerships and distribution footprint to drive rapid market share growth.
See More
Inspira Technologies Secures Major Procurement Approval
- Stock Surge: Inspira Technologies OXY (IINN) shares surged over 28% in pre-market trading on Monday, reflecting strong market interest and heightened investor confidence in the company's new product.
- Procurement Approval: Israel's largest health services provider, Clalit Health Services, approved the procurement of Inspira's FDA-cleared ART100 platform, marking a significant milestone in the medical device sector for the company.
- Market Reach: The ART100 system will be rapidly deployed across Clalit’s healthcare network, which serves approximately 4.9 million members, indicating a swift expansion of the company's market share and enhanced brand presence.
- Clinical Validation: The approval of ART100 represents not only a successful regulatory clearance but also strong clinical validation for its application in cardiopulmonary bypass and ECMO procedures, signaling substantial future commercial growth potential.
See More
Inspira Technologies Secures Clalit Approval for ART100 System
- Commercial Activation: Inspira Technologies' INSPIRA™ ART100 system has received approval from Clalit Health Services, marking its transition to commercial availability within a network serving approximately 4.9 million members, which is expected to significantly enhance the company's competitiveness in the medical device market.
- Network Scale: Clalit operates 14 major hospitals and over 1,600 clinics, and this approval allows the ART100 to penetrate one of the most sophisticated healthcare supply chains globally, further solidifying Inspira's market position in high-end medical devices.
- Clinical Value Validation: Following a rigorous technical and clinical review, the ART100's safety and efficacy have been strongly validated, providing a powerful reference case for Inspira's promotion in other global health systems and enhancing its market credibility.
- Long-Term Revenue Foundation: CEO Dagi Ben-Noon stated that this approval lays the groundwork for potentially long-term, high-quality revenue, and is expected to accelerate the company's commercialization efforts in the U.S. and other global markets.
See More
Inspira Technologies Validates HYLA System for Heart-Lung Surgery Market
- Market Penetration Opportunity: Inspira Technologies has successfully validated its HYLA™ system, which is expected to rapidly enter the approximately $50 billion heart-lung surgery market, marking a strategic expansion for the company in the medical device sector.
- Technical Performance Breakthrough: The HYLA™ system demonstrated a 94.2% accuracy in pCO₂ measurement during advanced lab testing, aligning with clinical needs and enabling real-time patient monitoring, thereby reducing complications during heart-lung machine and ECMO procedures.
- Standalone System Advantage: By decoupling the sensor from life-support hardware, the HYLA™ system achieves universal compatibility with existing operating room or ICU workflows, significantly expanding the company's total addressable market and activating a high-margin recurring revenue model.
- Future Development Strategy: The company plans to submit a regulatory application to the FDA in 2026, with CEO Dagi Ben-Noon stating that offering HYLA as a standalone solution will accelerate market entry and meet the substantial global demand for perfusion systems.
See More
Inspira Technologies Achieves Major Milestone in U.S. Hospital
- Clinical Evaluation Completed: Inspira's INSPIRA™ ART100 system has completed its clinical evaluation at a leading U.S. academic medical center, successfully treating approximately 30 patients, marking its transition from pilot use to standard clinical workflow and significantly enhancing the company's recognition in the medical device market.
- Procurement Process Initiated: The medical center has initiated an internal procurement process for multiple ART100 systems, indicating that the technology's clinical value and reliability have been thoroughly validated, which is expected to drive broader adoption of ART100 across other healthcare institutions.
- Technology Validation: The ART100 system is the first to progress from clinical evaluation to a budgeted procurement pathway at a major U.S. academic medical center, reflecting Inspira's competitiveness and market potential in the medical device sector, thereby strengthening its commercial positioning.
- Future Development Outlook: Inspira CEO Dagi Ben-Noon stated that this milestone will facilitate the broader adoption of the ART100 platform across leading healthcare institutions, further solidifying the company's market position in life support and MedTech.
See More
