INSPIRA™ ART100 system
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Inspira Completes Clinical Study for HYLA™ Blood Sensor - Ahead of Regulatory Submission
Globenewswire· 2025-11-13 14:00
Core Insights - Inspira Technologies has completed the clinical study for its non-invasive blood sensor, HYLA, and is preparing for regulatory submission and commercialization [1][2][4] - The HYLA sensor demonstrates an accuracy rate between 95% to 99% across various measured parameters, indicating its potential as a disruptive solution for real-time blood monitoring [2][4] - The company is integrating advanced Machine Learning algorithms to enhance the capabilities of the HYLA sensor, aiming to monitor critical physiological parameters not currently available through existing non-invasive systems [3][4] Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with its INSPIRA™ ART100 system cleared by the U.S. FDA for cardiopulmonary bypass and ECMO procedures [5] - The company is developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake and breathing spontaneously [5] - With a growing intellectual property portfolio and strategic operational streamlining, Inspira Technologies is positioning itself as an attractive player in the life-support and MedTech sectors [5]
Inspira Completes Clinical Study for HYLA™ Blood Sensor - Ahead of Regulatory Submission - Inspira Technologies Oxy (NASDAQ:IINN)
Benzinga· 2025-11-13 14:00
Core Insights - Inspira Technologies has completed the clinical study for its non-invasive blood sensor, HYLA, and is preparing for regulatory submission and commercialization [1][2][4] - The HYLA sensor demonstrates an accuracy rate between 95% to 99% across various measured parameters, indicating its potential as a disruptive solution for real-time blood monitoring [2][4] - The company is integrating advanced Machine Learning algorithms to enhance the capabilities of the HYLA sensor, aiming to monitor critical physiological parameters not currently available through existing non-invasive systems [3][4] Company Overview - Inspira Technologies is a commercial-stage medical device company focused on advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA ART100 system [5] - The company is developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake, further expanding its product offerings [5] - Inspira Technologies is positioned as an attractive player in the life-support and MedTech landscape, with a growing intellectual property portfolio and strategic operational streamlining [5]
Inspira Technologies Nears Final Regulatory Clearance for the ART100 in the UAE, Accelerating Gulf Region Expansion
Globenewswire· 2025-11-06 14:10
Core Insights - Inspira Technologies has completed the regulatory submission of its FDA-cleared INSPIRA™ ART100 system to the UAE Ministry of Health and Prevention, with final approval expected imminently, marking a significant step towards commercial entry into the Gulf region [1][2][3] Company Overview - Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions, with the INSPIRA™ ART100 system approved for cardiopulmonary bypass in the U.S. and ECMO procedures outside the U.S. [4] - The company is also developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake and spontaneously breathing, alongside advancing the HYLA™ blood sensor platform for continuous, non-invasive monitoring [4] Regulatory and Market Strategy - The regulatory milestone follows high-level discussions in the UAE, laying the groundwork for potential nationwide deployment and clinical integration of the ART100 system post-approval [2][3] - The UAE is recognized for its efficient and innovation-driven regulatory framework, which is expected to enhance Inspira's regional partnerships and unlock broad commercialization potential across the UAE's healthcare networks [3]
Inspira Appoints Former Johnson & Johnson Senior Business Manager as VP of Global Sales and New Board Member from a Leading International Investment Firm - Inspira Technologies Oxy (NASDAQ:IINN)
Benzinga· 2025-10-21 19:40
Core Insights - Inspira Technologies has announced two key leadership appointments to enhance its global commercialization and governance, with Mr. Mike Hershkovitz as Vice President of Global Sales and Ms. Sivan Matza as an independent director on the board [1][4][5] Leadership Appointments - Mr. Mike Hershkovitz brings nearly two decades of experience in U.S. and international healthcare markets, having held senior roles at Johnson & Johnson and other global med-tech organizations, and will lead Inspira's sales strategy and hospital adoption initiatives [3][5] - Ms. Sivan Matza, a director at a leading international investment management firm overseeing tens of billions of dollars in assets, will serve on the board's compensation, audit, and financial statement examination committees, strengthening the company's governance framework [2][4] Strategic Implications - The appointments are seen as a strategic step to enhance Inspira's capabilities, with a focus on accelerating commercial expansion and strengthening governance as the company grows [4][5] - The combined expertise of the new leaders is expected to act as a catalyst for Inspira's next phase of growth and execution, particularly in driving the adoption of its technologies in hospitals worldwide [5] Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with its INSPIRA™ ART100 system approved for cardiopulmonary bypass in the U.S. and ECMO procedures outside the U.S. [7] - The company is also developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake, and advancing the HYLA™ blood sensor platform for continuous, non-invasive monitoring [7] - With multiple cleared products and a growing IP portfolio, Inspira Technologies is positioned as an attractive player in the life-support and MedTech landscape, reflecting broader industry trends such as consolidation and potential strategic partnerships [7]
Inspira Appoints Former Johnson & Johnson Senior Business Manager as VP of Global Sales and New Board Member from a Leading International Investment Firm
Globenewswire· 2025-10-21 19:40
Core Insights - Inspira Technologies has announced two key leadership appointments to enhance its global commercialization and governance, with Mr. Mike Hershkovitz as Vice President of Global Sales and Ms. Sivan Matza as an independent director on the Board [1][4][5] Leadership Appointments - Mr. Mike Hershkovitz brings nearly two decades of experience in U.S. and international healthcare markets, having held senior roles at Johnson & Johnson and other global med-tech organizations, and will lead Inspira's sales strategy and hospital adoption initiatives [3][5] - Ms. Sivan Matza, a director at a leading international investment management firm overseeing tens of billions in assets, will serve on the Board's compensation, audit, and financial statement examination committees, strengthening the company's governance framework [2][4] Strategic Implications - The appointments are seen as a strategic step to enhance Inspira's capabilities, with a focus on accelerating commercial expansion and strengthening governance as the company grows [4][5] - The combined expertise of the new leaders is expected to act as a catalyst for Inspira's next phase of growth and execution, particularly in driving the adoption of its technologies in hospitals worldwide [5] Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA™ ART100 system for cardiopulmonary bypass and ECMO procedures [7] - The company is also developing the INSPIRA ART500 system and the HYLA™ blood sensor platform, positioning itself as an attractive player in the life-support and MedTech landscape [7]
Inspira Appoints Former Johnson & Johnson Executive as VP of Global Sales and New Board Member from a Leading International Investment Firm
Globenewswire· 2025-10-21 13:05
Core Insights - Inspira Technologies has announced two key leadership appointments to enhance its global commercialization and governance, with Mr. Mike Hershkovitz as Vice President of Global Sales and Ms. Sivan Matza as an independent director on the Board [1][4][5] Leadership Appointments - Mr. Mike Hershkovitz brings nearly two decades of experience in U.S. and international healthcare markets, having held senior roles at Johnson & Johnson and other global med-tech organizations [3] - Ms. Sivan Matza, a director at a leading international investment management firm, has extensive experience in global finance, regulation, and accounting, which will strengthen Inspira's governance framework [2] Strategic Implications - The appointments are seen as a strategic step to enhance Inspira's capabilities and drive its commercial strategy, particularly in accelerating the adoption of its technologies in hospitals worldwide [4][5] - The company aims to align its operations with long-term industry trends, including consolidation and potential strategic partnerships, as it continues to develop advanced medical technologies [7]
Inspira Appoints Former Johnson & Johnson Executive as VP of Global Sales and New Board Member from a Leading International Investment Firm - Inspira Technologies Oxy (NASDAQ:IINN)
Benzinga· 2025-10-21 13:05
Core Insights - Inspira Technologies has announced two key leadership appointments to enhance its global commercialization and governance, with Mr. Mike Hershkovitz as Vice President of Global Sales and Ms. Sivan Matza as an independent director on the board [1][4][5] Leadership Appointments - Mr. Mike Hershkovitz brings nearly two decades of experience in U.S. and international healthcare markets, having held senior roles at Johnson & Johnson and other global med-tech organizations [3] - Ms. Sivan Matza, a director at a leading international investment management firm, has extensive experience in global finance, regulation, and accounting, which will strengthen Inspira's governance framework [2] Strategic Implications - The appointments are seen as a strategic step to enhance Inspira's capabilities, with a focus on accelerating commercial expansion and strengthening governance [4][5] - The combined expertise of the new appointees is expected to serve as a powerful catalyst for Inspira's next phase of growth and execution [5] Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA™ ART100 system for cardiopulmonary bypass and ECMO procedures [7] - The company is also developing the INSPIRA ART500 system and the HYLA™ blood sensor platform, positioning itself as an attractive player in the life-support and MedTech landscape [7]
Inspira Appoints Former Johnson & Johnson Executive as VP of Global Sales and New Board Member from a Leading International Investment Firm
Globenewswire· 2025-10-21 13:05
Core Insights - Inspira Technologies has announced two key leadership appointments to enhance its global commercialization and governance, with Mr. Mike Hershkovitz as Vice President of Global Sales and Ms. Sivan Matza as an independent director on the Board [1][4][5] Leadership Appointments - Mr. Mike Hershkovitz brings nearly two decades of experience in U.S. and international healthcare markets, having held senior roles at Johnson & Johnson and other global med-tech organizations [3] - Ms. Sivan Matza, a director at a leading international investment management firm, has extensive experience in global finance, regulation, and accounting, which will strengthen Inspira's governance framework [2] Strategic Implications - The appointments are seen as a strategic step to enhance Inspira's capabilities and drive its commercial strategy, particularly in accelerating the adoption of its technologies in hospitals worldwide [4][5] - The company aims to align its operations with long-term industry trends, including consolidation and potential strategic partnerships, as it continues to develop advanced medical technologies [7]
Inspira Announces 97.3% Accuracy Results for HYLA™ Blood Sensor, Advancing Toward FDA Submission for Clearance
Globenewswire· 2025-09-11 13:30
Core Insights - Inspira Technologies announced pivotal results for its HYLA blood sensor, achieving 97.35% accuracy in performance testing, which supports its upcoming FDA submission [1][2][6] - The HYLA sensor is designed for continuous, real-time monitoring of key blood parameters, addressing urgent needs in operating rooms and critical care [3][6] - The company is positioned to penetrate the broader disposables market with a planned razor-and-blade recurring revenue model [2][6] Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA ART100 system [4] - The company is advancing the HYLA platform, which offers continuous, non-invasive monitoring and is compatible with various medical procedures [4][6] - Recent internal shifts within the company may align with broader industry trends such as consolidation and potential strategic partnerships [4]
Inspira Announces 97.3% Accuracy Results for HYLA™ Blood Sensor, Advancing Toward FDA Submission for Clearance - Inspira Technologies Oxy (NASDAQ:IINN)
Benzinga· 2025-09-11 13:30
Core Insights - Inspira Technologies announced pivotal results for its HYLA blood sensor, achieving 97.35% accuracy in performance testing, which supports its upcoming FDA submission [1][6] - The HYLA sensor is designed for continuous, real-time monitoring of key blood parameters, addressing urgent needs in operating rooms and critical care [3][6] - The company is positioned to penetrate the broader disposables market with a planned razor-and-blade recurring revenue model [2][4] Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with its FDA-cleared INSPIRA™ ART100 system approved for cardiopulmonary bypass in the U.S. and ECMO procedures outside the U.S. [4] - The company is developing the next-generation INSPIRA ART500 system, which aims to deliver oxygenation while patients remain awake and spontaneously breathing [4] - Inspira Technologies has a growing IP portfolio and is strategically streamlining operations to align with long-term industry trends, including consolidation and potential strategic partnerships [4] Product Features - The HYLA Blood Sensor provides continuous monitoring, delivering second-by-second data without the need for intermittent blood draws [6] - It utilizes non-invasive optical measurement technology, making it versatile for various medical procedures, including cardiopulmonary bypass and dialysis [6] - The sensor's modular design is engineered to complement existing medical devices, targeting the two million annual open-heart surgery patients globally [6]