This section highlights FDA-related milestones and regulatory updates for drugs developed by Inspira Technologies OXY B.H.N. (IINN).
Over the past two years, Inspira Technologies OXY B.H.N. has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
HYLA™, INSPIRA, and ART100. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
HYLA™ FDA Regulatory Timeline and Events
HYLA™ is a drug developed by Inspira Technologies OXY B.H.N. for the following indication: Blood Sensor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HYLA™
- Announced Date:
- September 11, 2025
- Indication:
- Blood Sensor
Announcement
Inspira™ Technologies announced pivotal results for its HYLA blood sensor, achieving 97.35% accuracy in its latest performance testing phase that will support its upcoming U.S. Food and Drug Administration ("FDA") submission.
AI Summary
Inspira Technologies, a pioneer in life-support and diagnostic tools, announced pivotal results for its HYLA blood sensor. In the latest performance testing, HYLA achieved 97.35% accuracy compared to standard blood gas analyzers. These results will support its upcoming submission to the U.S. Food and Drug Administration and mark a major step toward approval.
HYLA offers continuous, second-by-second monitoring without drawing blood. Its non-invasive optical technology tracks key blood parameters in real time. The sensor plugs into existing medical setups for open-heart surgery, extracorporeal membrane oxygenation, dialysis, and continuous renal replacement therapy. Its modular design aims to serve over two million annual bypass patients worldwide.
By enabling instant alerts and eliminating delays from lab tests, HYLA can transform critical care decisions. The company plans to market HYLA both alongside its ART device line and as a standalone product, using a razor-and-blade revenue model. With strong performance data in hand, Inspira is positioned for regulatory approval and commercial growth.
Read Announcement- Drug:
- HYLA™
- Announced Date:
- March 5, 2025
- Indication:
- Blood Sensor
Announcement
Inspira Technologies* has reported exceptional clinical study outcomes for its HYLA blood sensor, with 96% accuracy achieved in a key parameter compared to traditional blood analyzers.
AI Summary
Inspira Technologies has achieved groundbreaking clinical results with its AI-powered HYLA blood sensor. In a recent study conducted at a leading medical institution, the sensor demonstrated a 96% accuracy rate in monitoring a key blood parameter compared to traditional blood analyzers. This precise measurement underscores the sensor’s potential as a non-invasive, clip-on device for continuous blood monitoring during critical procedures.
The clinical evaluation also showed a 92.3% accuracy in detecting oxygen deficiencies, an important factor in preventing hypoxia during surgeries. These exceptional outcomes validate the reliability of Inspira’s innovative technology and highlight its ability to provide real-time data without the need for blood draws. Such results are expected to strengthen the company’s position in the blood gas analyzer market and pave the way for broader adoption in healthcare settings.
Read Announcement- Drug:
- HYLA™
- Announced Date:
- March 4, 2025
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- H2 2025
- Indication:
- Blood Sensor
Announcement
Inspira™ Technologies OXY B.H.N. Ltd. announced that FDA submission planned for H2 2025
AI Summary
Inspira Technologies OXY B.H.N. Ltd is taking a significant step forward with its non-invasive, AI-powered HYLA blood sensor. The device continuously monitors blood in real time without the need for traditional blood draws, and recent clinical studies have confirmed its high accuracy in detecting key blood parameters. Based on these promising results, the company announced plans to submit its first HYLA configuration to the U.S. Food and Drug Administration in the second half of 2025.
If the FDA submission is successful and clearance is obtained, the HYLA system will be deployed in U.S. hospitals for ongoing data collection and post-market validation. This advancement aims to improve patient care by enabling early diagnosis and more timely medical interventions, marking an important milestone in Inspira’s efforts to enhance monitoring during critical care procedures.
Read Announcement- Drug:
- HYLA™
- Announced Date:
- March 4, 2025
- Indication:
- Blood Sensor
Announcement
Inspira™ Technologies OXY B.H.N. Ltd announced positive results from the clinical study of its AI-powered HYLA™ blood sensor.
AI Summary
Inspira Technologies OXY B.H.N. Ltd. announced positive results from its clinical study of the AI-powered HYLA blood sensor. The sensor demonstrated a 96% accuracy rate for a key blood parameter compared to traditional analyzers. Additionally, a new indicator for detecting oxygen deficiencies achieved 92.3% accuracy. These promising results suggest that the HYLA sensor could provide real‐time blood monitoring without the need for repetitive blood draws, potentially leading to earlier diagnoses and more personalized patient care.
Following these successful outcomes, Inspira plans to continue its clinical study and expand its data collection to further improve the device’s AI learning capabilities. The company is also preparing for an FDA submission in the second half of 2025, with the aim of deploying this innovative technology in U.S. hospitals for enhanced critical care monitoring during various medical procedures.
Read Announcement- Drug:
- HYLA™
- Announced Date:
- August 28, 2024
- Indication:
- Blood Sensor
Announcement
Inspira Technologies OXY B.H.N. announced plans to report clinical results for its new HYLA™ blood sensor in open-heart surgery patients.
AI Summary
Inspira Technologies OXY B.H.N. announced plans to report clinical results for its new HYLA™ blood sensor in open-heart surgery patients. The innovative, clip-on device continuously monitors blood parameters in real time, alerting physicians immediately to any changes in a patient’s condition without the need for intermittent blood samples. This development is set to provide critical data during surgeries and in intensive care settings, where timely information can be life-saving. Inspira sees the clinical study as a key milestone in advancing its growth plans and further establishing the HYLA™ sensor’s role in modern medical care. The results, expected by the fourth quarter of 2024, will help validate the sensor’s performance and bolster future plans, including a submission for FDA clearance in early 2025.
Read Announcement
INSPIRA Cardi-ART FDA Regulatory Events
INSPIRA Cardi-ART is a drug developed by Inspira Technologies OXY B.H.N. for the following indication: To Provide Oxygen to the Brain During Cardiac Arrest.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INSPIRA Cardi-ART
- Announced Date:
- September 2, 2025
- Indication:
- To Provide Oxygen to the Brain During Cardiac Arrest
Announcement
Inspira™ Technologies OXY B.H.N. Ltd. announced that a top U.S. hospital, has expanded its clinical use of the INSPIRA™ ART100 system to lung transplantation procedures, one of the most demanding applications in advanced respiratory care.
AI Summary
Inspira Technologies announced that a top U.S. hospital has expanded its clinical use of the INSPIRA™ ART100 system to lung transplantation procedures. This hospital, ranked among the top 20 in the nation by U.S. News & World Report, already had success with the device in earlier cases.
By using the ART100 in lung transplants—a highly complex and demanding surgery—the hospital shows strong confidence in the device’s performance. The expansion highlights the ART100’s reliability and clinical value in advanced respiratory support.
Dagi Ben-Noon, CEO of Inspira Technologies, said that this move is a meaningful step that reflects growing trust in the technology. He noted the potential for ART100 to become a standard platform in the most complex surgical settings.
This clinical expansion underscores Inspira’s momentum in the life-support market and points to a future where the ART100 system supports multiple critical care applications.
Read Announcement- Drug:
- INSPIRA Cardi-ART
- Announced Date:
- July 30, 2024
- Indication:
- To Provide Oxygen to the Brain During Cardiac Arrest
Announcement
Inspira Technologies OXY B.H.N. proudly announces introduces the INSPIRA Cardi-ART, a portable modular device, currently in development, to provide oxygen to the brain during cardiac arrest (the "Device" or "INSPIRA Cardi-ART").
AI Summary
Inspira Technologies OXY B.H.N. Ltd. announced the development of the INSPIRA Cardi-ART, a portable modular device that delivers oxygen to the brain during cardiac arrest. This innovative device is designed to provide vital oxygenation during emergencies, helping support critical organs during CPR, whether in a hospital or in the field. With nearly 70% of cardiac arrests occurring outside hospital settings and survival rates below 10%, the Cardi-ART aims to address a huge unmet need in life-saving care. The device leverages Inspira’s advanced blood oxygenation and monitoring technology, including their cutting-edge HYLA blood sensor, to rapidly measure vital parameters and deliver oxygenated blood to reduce damage during cardiac arrest. Inspira plans to submit the INSPIRA Cardi-ART to the U.S. Food and Drug Administration for review as early as 2026, pending the final regulatory pathway.
Read Announcement
ART100 FDA Regulatory Timeline and Events
ART100 is a drug developed by Inspira Technologies OXY B.H.N. for the following indication: Cardio-Pulmonary Bypass Device.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ART100
- Announced Date:
- July 7, 2025
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira™ Technologies OXY B.H.N. Ltd. announced that it is engaged in high-level talks with a government health authority, located outside of the United States, which are intended to advance the national integration of its FDA-cleared ART100 system as a foundational component of the national emergency infrastructure and to establish a global distribution framework.
AI Summary
Inspira™ Technologies OXY B.H.N. Ltd. announced it is in high-level talks with a government health authority located outside the United States. The discussions aim to integrate the company’s FDA-cleared ART100 system as a key component of the nation’s emergency infrastructure. This strategic move is designed to embed the ART100 system into the national emergency framework, highlighting its role in enhancing preparedness during critical situations.
The planned meeting on July 8, 2025, will focus on setting the key terms and a roadmap for the collaboration. A major part of this effort includes establishing a global distribution framework that leverages the government authority’s extensive international reach. This step is expected to pave the way for broader global partnerships and boost the profitability tied to its significant purchase orders, marking a shift from regional to government-level engagements.
Read Announcement- Drug:
- ART100
- Announced Date:
- July 2, 2025
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira™ Technologies OXY B.H.N. Ltd. announced it has secured a binding $22.5 million purchase order for its FDA-cleared ART100 system, representing a major commercial inflection point for the Company.
AI Summary
Inspira™ Technologies OXY B.H.N. Ltd. has reached a major commercial milestone by securing a binding $22.5 million purchase order for its FDA-cleared ART100 system. This order, placed by a privately held company outside the United States, is set to be fully paid during 2025. The agreement marks a significant step for Inspira, signaling a clear transition from early-stage trials to full-scale revenue generation.
The strong vote of confidence in the ART100 system comes after its successful clinical use in top U.S. medical centers, laying the foundation for future global deployments. Inspira considers this purchase order as just the beginning, highlighting the broader market potential for their innovative life-support and diagnostic technologies. The Company has already initiated onboarding, logistics planning, and deployment scheduling as it moves toward continued commercial expansion.
Read Announcement- Drug:
- ART100
- Announced Date:
- June 11, 2025
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira™ Technologies OXY B.H.N. Ltd. announced that that its FDA-cleared ART100 system adoption has begun to positively impact commercialization interest and efforts, representing a key milestone and significantly contributes to the Company's commercial validation.
AI Summary
Inspira™ Technologies OXY B.H.N. Ltd. announced that its FDA-cleared ART100 system is now making a significant impact on commercialization efforts. The adoption of the ART100 system at top-tier U.S. hospitals marks a key milestone and contributes notably to the company’s commercial validation. This integration into real clinical workflows demonstrates strong confidence from the medical community in the system’s ability to support patients in critical condition. The consistent use of the ART100 has spurred further interest from additional U.S. healthcare institutions, international bodies, and governmental authorities. As a result, Inspira is actively engaging in discussions with various stakeholders and scaling up its operational capabilities to meet anticipated demand. This development reinforces Inspira’s position at the forefront of life-support and diagnostic technologies as it continues to drive its global rollout and commercial expansion strategy.
Read Announcement- Drug:
- ART100
- Announced Date:
- May 29, 2025
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira™ Technologies OXY B.H.N. Ltd. announced a strategic shift to accelerate the commercialization of its U.S. FDA (Food and Drug Administration)-cleared INSPIRA™ ART100 system (the "ART100"), while maintaining the development and regulatory pathways of its portfolio of products.
AI Summary
Inspira Technologies OXY B.H.N. Ltd. has announced a strategic shift to accelerate the commercialization of its U.S. FDA-cleared INSPIRA™ ART100 system. The company is actively engaging in sales discussions at several U.S. locations to bring the ART100, now used in real-world clinical settings, into broader use in critical care environments. By fast-tracking its market entry, Inspira aims to address the growing demand for innovative respiratory solutions while laying the groundwork for substantial near-term revenue and long-term shareholder value.
Alongside this accelerated commercialization effort, the company remains committed to advancing the development and regulatory pathways of its entire product portfolio. This dual approach underscores Inspira’s focus on both immediate market needs and continued innovation, positioning the company strongly within the competitive MedTech landscape moving forward.
Read Announcement- Drug:
- ART100
- Announced Date:
- May 7, 2025
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira™ Technologies OXY B.H.N. Ltd. announced that the INSPIRA™ ART100 has been approved by Israel's largest healthcare provider to undergo a clinical validation by leading physicians who intend to use the innovative life-support and diagnostic device during organ transplant procedures.
AI Summary
Inspira™ Technologies OXY B.H.N. Ltd. has gained significant recognition as Israel’s largest healthcare provider has approved the INSPIRA™ ART100 system for clinical validation by leading physicians. The innovative life-support and diagnostic device will be put to the test during organ transplant procedures at one of the country’s renowned medical centers. Transplant specialists will use the system to explore its unique ability to maintain organ viability by providing out-of-body blood oxygenation before, during, and after surgery. This clinical evaluation will allow physicians to gather real-world insights into the device’s performance in highly complex transplant settings. The resulting data is expected to further support Inspira’s plans to enhance and advance its critical care technologies, ensuring improved patient care and outcomes during high-risk organ transplant procedures.
Read Announcement- Drug:
- ART100
- Announced Date:
- April 7, 2025
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira™ Technologies announced the successful completion of the first human treatment using its U.S. Food and Drug Administration-cleared INSPIRA™ ART100 system in a critical life-support procedure.
AI Summary
Inspira™ Technologies recently marked a milestone by completing the first human treatment using its FDA-cleared INSPIRA™ ART100 system. The breakthrough procedure took place at Westchester Medical Center in New York, where top physicians used the system to deliver vital heart and lung support during a critical life-support case. The ART100 system successfully oxygenated and circulated the patient’s blood, allowing for safe stabilization and a smooth transition off the device following treatment.
Dr. David Spielvogel, Section Chief of Cardiothoracic Surgery at Westchester Medical Center, praised the system for its reliability and responsive performance throughout the procedure. This significant achievement highlights the clinical readiness and potential impact of the INSPIRA™ ART100 system for advanced extracorporeal support technology, promising improvements in patient care during life-critical situations.
Read Announcement- Drug:
- ART100
- Announced Date:
- March 25, 2025
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira™ Technologies OXY B.H.N. Ltd. announced that it has successfully completed the installation, training program and operational readiness for its INSPIRA ART100 system for cardiopulmonary bypass procedures at one of New York's premier hospitals.
AI Summary
Inspira Technologies OXY B.H.N. Ltd. announced a significant milestone in its U.S. expansion by successfully completing the installation, training program, and operational readiness for its INSPIRA ART100 system at one of New York’s premier hospitals.
The INSPIRA ART100 system is designed for cardiopulmonary bypass procedures, and this achievement marks a key step toward its first human clinical use. The hospital’s expert team has been thoroughly trained to operate the system, which is expected to soon be used on patients undergoing such procedures. This rollout not only validates the clinical value of Inspira’s innovative approach but also positions the company for further growth within the U.S. healthcare market by providing critical early feedback and paving the way for wider clinical adoption.
Read Announcement- Drug:
- ART100
- Announced Date:
- January 27, 2025
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira Technologies OXY B.H.N. announced the addition of new support features to the INSPIRA™ ART100, a system cleared by the U.S. Food and Drug Administration.
AI Summary
Inspira Technologies OXY B.H.N. has introduced new support features to its INSPIRA™ ART100 system, which is already cleared by the U.S. Food and Drug Administration. These updates aim to ease the workload on healthcare staff by streamlining medical procedures and integrating with hospitals' existing safety protocols. The enhancements include system-activated alarm troubleshooting to guide users during emergencies, and an improved display screen that shows important information clearly even in challenging care situations such as patient isolation or transit.
The company’s CEO, Dagi Ben-Noon, explained that these new features are designed to help medical teams work more efficiently and reduce stress during critical procedures. This step reinforces Inspira’s commitment to innovative medical technology that supports healthcare professionals in delivering faster and more effective patient care.
Read Announcement- Drug:
- ART100
- Announced Date:
- January 10, 2025
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira Technologies OXY B.H.N. announced today that it is preparing for a potential production ramp-up of its INSPIRA™ ART100 device
AI Summary
Inspira Technologies OXY B.H.N. announced that it is getting ready to potentially ramp up production of its INSPIRA™ ART100 device. This step comes as a precaution in response to the recent human metapneumovirus (hMPV) outbreak in China. With a focus on providing advanced respiratory care solutions, the company is in talks with key healthcare providers in regions hit by the outbreak to assess the demand for its innovative device. Inspira is also coordinating with its suppliers to secure the raw materials and components needed for a swift production increase if required.
The company’s move demonstrates a proactive approach to ensuring that healthcare providers have timely access to essential respiratory support equipment. Inspira is closely monitoring the evolving situation among global health authorities and is prepared to adjust its production plans to meet any potential surge in the need for advanced respiratory care technologies.
Read Announcement- Drug:
- ART100
- Announced Date:
- January 7, 2025
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira Technologies Oxy B.H.N. Ltd. announced that the INSPIRA™ ART100, a cardiopulmonary bypass system will be showcased at Arab Health 2025, one of the largest healthcare exhibitions in the Middle East, expected to have over 3,800 exhibitors and over 180 visiting countries
AI Summary
Inspira Technologies Oxy B.H.N. Ltd. announced that its INSPIRA™ ART100, a state-of-the-art cardiopulmonary bypass system, will be showcased at Arab Health 2025 in Dubai. This major healthcare event, held from January 27th to January 30th at the Dubai World Trade Center, is one of the largest in the Middle East, expecting over 3,800 exhibitors and representatives from more than 180 countries.
The INSPIRA™ ART100 system is designed to enhance patient care by adding oxygen to the blood and removing carbon dioxide, effectively supporting patients when the heart and lungs are under stress. The system features proprietary software for easy setup and advanced alarm management to assist medical teams during emergencies. Inspira’s global presence at Arab Health 2025 offers a significant opportunity to introduce its innovative respiratory care technology to new markets and forge valuable partnerships.
Read Announcement- Drug:
- ART100
- Announced Date:
- December 4, 2024
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira Technologies OXY B.H.N. entered into a strategic collaboration with Westchester Medical Center in Valhalla, New York. Westchester Medical Center, the flagship hospital in the Westchester Medical Center Health Network, will evaluate the performance and effectiveness of the new U.S. Food and Drug Administration (FDA) cleared INSPIRA ART100 systems in various real-world clinical scenarios, exposing Inspira's products and technologies to leading physicians and medical institutions.
AI Summary
Inspira Technologies OXY B.H.N. recently announced a strategic collaboration with Westchester Medical Center in Valhalla, New York. Under this partnership, the flagship hospital of the Westchester Medical Center Health Network will evaluate the performance and effectiveness of Inspira’s FDA cleared INSPIRA ART100 systems in real-world clinical settings. This collaboration provides an opportunity for Inspira to showcase its innovative life support technology to leading physicians and top medical institutions. By testing the INSPIRA ART100 systems, Westchester Medical Center aims to advance critical patient care, particularly in managing acute respiratory conditions, demonstrating the practical benefits of Inspira's technology. The evaluation will help validate the system’s capabilities and potentially lay the groundwork for further integration and long-term administration of future Inspira products.
Read Announcement- Drug:
- ART100
- Announced Date:
- August 22, 2024
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira Technologies OXY B.H.N. Ltd. announces the U.S. Food and Drug Administration ("FDA") listing of its medical cart (INSPIRA™ CART) which has been custom designed for use with the INSPIRA™ ART100 system.
AI Summary
Inspira Technologies OXY B.H.N. Ltd. announced that the U.S. Food and Drug Administration (FDA) has listed its INSPIRA™ CART. This medical cart has been custom designed to work with the INSPIRA™ ART100 system and is intended for use by healthcare professionals in operating rooms during cardiopulmonary bypass procedures. The device is classified as a Class I Medical Device and is exempt from the 510(k) process, showing that it meets the required safety and efficacy standards for use in the U.S. market.
With this FDA listing, the INSPIRA™ CART is set to help streamline healthcare delivery by transforming the INSPIRA™ ART100 system into a mobile workstation. This innovation supports medical teams in administering care quickly and efficiently across various clinical settings, reinforcing Inspira’s ongoing commitment to advancing life-support technology.
Read Announcement- Drug:
- ART100
- Announced Date:
- August 13, 2024
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira Technologies OXY B.H.N. announced that it was approached by a leading medical technology company in the industry, to evaluate the operation of its proprietary key product in combination with the INSPIRA™ ART100 system.
AI Summary
Inspira Technologies OXY B.H.N. recently announced that it was approached by a prominent medical technology company to evaluate the performance of its key proprietary life-support product together with the INSPIRA™ ART100 system. The evaluation, performed in Inspira’s advanced laboratory under strict regulatory guidelines, demonstrated that the integrated system exceeded the standard gas transfer value at maximum flow. Researchers simulated various conditions by continuously monitoring blood parameters across different flow rates, ensuring that the product functioned effectively under scenarios similar to those seen in patients with oxygen-deficient and carbon dioxide-rich blood. Inspira’s CEO, Dagi Ben-Noon, highlighted that these findings confirm the compatibility and high performance of the INSPIRA™ ART100 system, showcasing its potential to enhance existing medical technologies and improve patient care. The successful evaluation is seen as a promising foundation for further partnerships and innovations in respiratory and life-support technology.
Read Announcement- Drug:
- ART100
- Announced Date:
- July 11, 2024
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
- Inspira™ Technologies OXY announce the receipt of the Israeli Ministry of Health's medical devices and accessories ("AMAR") approval for the INSPIRA™ ART100, an Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system.
AI Summary
Inspira™ Technologies OXY announced that it has received AMAR approval from the Israeli Ministry of Health for the INSPIRA™ ART100, a state-of-the-art Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system. This milestone highlights the Company’s ability to meet strict regulatory standards and move closer to expanding its market presence. The approval is expected to boost local support and pave the way for new business opportunities in emerging markets.
Medical professionals are optimistic about the impact of the INSPIRA™ ART100, noting that the innovative technology can help hospitals quickly elevate patients’ oxygen levels. Inspira’s CEO, Dagi Ben-Noon, emphasized that this achievement is crucial for the Company’s strategy to grow its global footprint and advance life support solutions that can enhance patient care in various medical settings.
Read Announcement- Drug:
- ART100
- Announced Date:
- May 28, 2024
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira™ Technologies OXY B.H.N. Ltd announced that it has received notification of 510(k) class II clearance from the U.S. Food and Drug Administration (FDA) for its INSPIRA™ ART100, a Cardiopulmonary Bypass
AI Summary
Inspira™ Technologies OXY B.H.N. Ltd. recently announced that it received 510(k) Class II clearance from the U.S. Food and Drug Administration (FDA) for its INSPIRA™ ART100, a Cardiopulmonary Bypass system. This clearance confirms that the INSPIRA™ ART100 meets the necessary FDA requirements for safety and effectiveness. The device is designed to support heart and lung functions during surgical procedures, playing a crucial role in maintaining blood circulation and oxygenation.
Dagi Ben Noon, CEO of Inspira, expressed pride in reaching this milestone and thanked their investors and partners. Professor Benad Goldwasser, Chairman of the Board, highlighted the FDA clearance as a key example of the company’s ongoing advancements in medical technology. This achievement reinforces Inspira Technologies' commitment to developing innovative life support solutions that can improve patient care in various medical settings.
Read Announcement- Drug:
- ART100
- Announced Date:
- May 2, 2024
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira™ Technologies OXY B.H.N. Ltd announced the start of production of the INSPIRA ART100 medical device.
AI Summary
Inspira™ Technologies OXY B.H.N. Ltd. announced that it has begun production of its new INSPIRA ART100 medical device. This innovative device is designed to help balance patient oxygen levels and offer an alternative approach to invasive mechanical ventilation. The INSPIRA ART100 is being produced by a leading technology company that specializes in high-technology electronic assembly solutions for industries such as medical, aerospace, communications, and defense. The first batch of the device is now under assembly and will be deployed at initial sites once it receives regulatory clearance from the U.S. Food and Drug Administration. This development marks a significant step forward for Inspira in the respiratory treatment arena, as the company continues to advance its breakthrough Augmented Respiration Technology aimed at reducing the need for risky and costly traditional ventilation methods.
Read Announcement- Drug:
- ART100
- Announced Date:
- April 25, 2024
- Indication:
- Cardio-Pulmonary Bypass Device
Announcement
Inspira™ Technologies OXY B.H.N. Ltd announced that it has received the Canadian Standards Association (CSA) Certification of Compliance to U.S. standards for the INSPIRA ART100 device.
AI Summary
Inspira™ Technologies OXY B.H.N. Ltd. announced that its INSPIRA ART100 device has earned the Canadian Standards Association (CSA) Certification of Compliance to U.S. standards. This certification confirms that the device meets high safety and performance requirements as tested by the CSA, allowing the product to bear the CSA Mark (C878081) for medical electrical equipment/systems.
The company views the CSA certification as an important milestone that highlights its commitment to quality and safety. Although the device has not yet received clearance from the U.S. Food and Drug Administration (FDA), obtaining the CSA mark represents significant progress for Inspira in its drive to secure market access for the INSPIRA ART100. This achievement supports the company’s goal of providing innovative respiratory treatment solutions while ensuring rigorous safety standards are met.
Read Announcement
