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Inspira Technologies Oxy BHN Ltd (IINN) delivers innovative respiratory care solutions through its non-invasive INSPIRA ART system and HYLA blood monitoring technology. This page provides investors and healthcare professionals with essential updates on regulatory milestones, product developments, and clinical partnerships shaping the future of critical care.
Access real-time information on FDA clearances, technology evaluations, and strategic collaborations. Our curated news ensures you stay informed about advancements in extracorporeal oxygenation and AI-driven blood analytics without speculative commentary.
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Bookmark this page for streamlined access to Inspira Technologies' progress in redefining respiratory support systems. Check back regularly for authoritative reporting on innovations addressing acute respiratory failure and ICU resource challenges.
Inspira Technologies (Nasdaq: IINN) has announced plans to report clinical results for its HYLA™ blood sensor in Q4 2024. The clip-on sensor aims to alert physicians of changes in a patient's condition without intermittent blood samples, targeting a potential $2.5 billion Point of Care testing and Arterial Blood Gas analyzer market. Inspira is expanding its blood testing facilities to accelerate HYLA™ development, with a 510(k) submission to the FDA planned for early 2025.
The company's broader strategy involves transforming respiratory and life-support sectors, addressing an estimated $59 billion annual market opportunity. Inspira plans to deploy its FDA-cleared INSPIRA™ ART100 system in top U.S. and Israeli hospitals. The company is also developing additional products, including the INSPIRA™ ART (Gen 2) and INSPIRA™ Cardi-ART, focusing on innovative oxygenation and blood monitoring technologies.
Inspira Technologies OXY B.H.N. (IINN) has announced the FDA listing of its INSPIRA™ CART, a medical cart designed for use with the INSPIRA™ ART100 system. This Class I Medical Device, 510(K) Exempt, is intended for use in operating rooms during Cardiopulmonary Bypass procedures. The company aims to streamline healthcare delivery and transform the ART100 system into a mobile workstation.
Inspira is developing novel life support-extending technologies, targeting a combined market opportunity of approximately $59 billion annually. The company's product pipeline includes the HYLA™ blood sensor, INSPIRA™ Cardi-ART, and INSPIRA™ ART (Gen 2). These technologies are designed to monitor blood parameters, support cardiac arrest patients, and provide adaptive blood oxygenation, respectively.
Inspira Technologies (Nasdaq: IINN) has announced that a leading medical technology company approached them to evaluate the operation of their key product in combination with the INSPIRA™ ART100 system. The evaluation, conducted by Inspira researchers, showed that test results exceeded 100% of the standard value for gas transfer at maximum flow when integrated with the ART100 system.
The tests were performed in Inspira's advanced laboratory, simulating oxygen-deficient and carbon dioxide-rich blood conditions. The successful results demonstrate the power and versatility of the INSPIRA™ ART100 system in various technology settings. Inspira believes this validates the system's compatibility and performance with key products of a leading medical technology company, potentially leading to meaningful business development activities.
Inspira Technologies (Nasdaq: IINN) has introduced the INSPIRA Cardi-ART, a portable modular device designed to provide oxygen to the brain during cardiac arrest. This innovation targets the $39.8 billion global cardiac arrest market, expanding Inspira's potential market to approximately $58.8 billion. The device aims to improve survival rates for cardiac arrest patients, particularly outside hospitals where the mortality rate is about 90%.
Key features of the INSPIRA Cardi-ART include:
- Fast emergency response during CPR
- Rapid cannulation and oxygenated blood delivery
- Monitoring of vital parameters using HYLA blood sensor technology
- Hemodynamic support in case of cardiac failure
Inspira plans to submit the device for FDA regulatory approval as early as 2026, pending the final regulatory pathway.
Inspira Technologies has received approval from the Israeli Ministry of Health for its INSPIRA™ ART100 system, an Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system. This approval follows the FDA clearance announced on May 28, 2024.
Both approvals are critical milestones, enhancing the company's market opportunities in the U.S. and Israel. The INSPIRA™ ART100, equipped with Adaptive Blood Oxygenation technology, measures blood parameters in real-time to deliver oxygen directly into the blood.
CEO Dagi Ben-Noon and Dr. Dekel Stavi highlight the significance of these approvals for business expansion and local adoption. The company aims to revolutionize respiratory and life-support technologies with further product development, although some products like the INSPIRA™ ART (Gen 2) and HYLA™ blood sensor remain untested and unapproved by any regulatory bodies.
Inspira Technologies OXY B.H.N. (Nasdaq: IINN) announced its business plan targets on June 20, 2024, focusing on the promotion of the INSPIRA™ ART100 following FDA clearance and the acceleration of the INSPIRA™ ART (Gen2).
The company aims to capture a share of the $19 billion mechanical ventilation market by 2030, with plans to deploy INSPIRA ART100 in multiple sites and countries. The first purchase order from the U.S. distributor has been received, with the first shipment scheduled for Q4 2024.
Key goals include the submission of the HYLA™ blood sensor for FDA clearance and ongoing development of the VORTX™ blood delivery system. The company believes the success of INSPIRA ART100 will pave the way for future breakthroughs with INSPIRA ART (Gen2).
Inspira Technologies (Nasdaq: IINN) announced its participation at the annual iECOs Conference in Herzliya, Israel, on June 18, 2024.
The company will showcase the INSPIRA™ ART100 System, which recently received 510(k) clearance from the U.S. FDA and is pending approval from Israel's AMAR.
Inspira's R&D team will be available to discuss their advanced life support solutions and other technologies in development.
For meetings, attendees can contact the company via info@inspira02.com.
Inspira Technologies has announced its first purchase order for the INSPIRA ART100 systems from Glo-Med Networks. This order includes five units expected to ship in Q4 2024, with a potential for 20 additional units pending further agreements. This milestone follows the recent FDA clearance of the INSPIRA ART100 and marks a significant step in Inspira's growth strategy. The INSPIRA ART100, part of a new generation of devices targeting the $19 billion mechanical ventilator market, aims to reduce the need for traditional mechanical ventilation. The company also plans to offer hospitals special terms for the integrated HYLA Blood Sensor and INSPIRA ART (Gen 2) devices, pending regulatory approvals and product development.
Inspira Technologies (Nasdaq: IINN) announces plans to exhibit its FDA-cleared INSPIRA™ ART100 System at the ELSO conference in Detroit, Michigan, from September 29 to October 1, 2024. The event offers a platform to showcase the system to healthcare representatives and strategic partners. The INSPIRA™ ART100 is designed for cardiopulmonary bypass procedures, offering advanced software and portability. This system supports use with various disposables and will be demoed to potential buyers and partners, facilitating pre-scheduled meetings. The event will be discussed further in a conference call on June 20, 2024.
Inspira Technologies OXY B.H.N. (Nasdaq: IINN, IINNW) announced significant milestones, including FDA clearance for its INSPIRA™ ART100 system. The company will present its business targets and distribution agreements in a conference call on June 20, 2024, at 9:00 am Eastern Time. Company President and co-founder Joe Hayon will lead the discussion, providing insights into Inspira's future steps.
