Linde Gas Submits FDA 510(k) for Advanced Inhaled Nitric Oxide System
In a significant advancement for healthcare, Linde Gas & Equipment Inc. has submitted a 510(k) premarket notification application to the United States Food and Drug Administration (FDA) for its new NOXBOX® I PLUS, a nitric oxide delivery and monitoring system, specifically designed for administering NOXIVENT® (nitric oxide) for inhalation. This latest submission marks a continuation of Linde’s commitment to innovating solutions for respiratory therapies.
According to Jason Aexel, the Director of Clinical Healthcare at Linde Gas & Equipment Inc., the introduction of the NOXBOX® I PLUS aims to provide healthcare professionals with an efficient, economical, and reliable method to deliver inhaled nitric oxide therapy. This development builds upon the success of their existing NOXBOX®i delivery system, which has been operational in over 40 countries since 2013 and in the U.S. since late 2018, widely employed across numerous healthcare facilities.
The NOXBOX® I PLUS features several enhancements designed to improve its usability. Key modifications include an easier setup process, ergonomic enhancements, and precise controls. These upgrades ensure compatibility with various ventilators, ensuring a better user experience for healthcare providers.
Aexel expressed enthusiasm for the potential to gain 510(k) clearance for this updated system, emphasizing Linde's ongoing dedication to improving nitric oxide therapy technology. The company aims to provide high-quality services and deliver advancements that enhance patient care and safety.
Linde's NOXIVENT (nitric oxide) gas is particularly beneficial for neonates, intended to improve oxygenation and lessen dependence on extracorporeal membrane oxygenation in cases of hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. It is a critical agent used alongside ventilatory support and other relevant medicines for patients that meet specified conditions.
The introduction of the NOXBOX® I PLUS signifies not just a step forward in technology but also highlights Linde's commitment to safety protocols. The company reminds users that NOXIVENT is contraindicated in neonates with specific blood shunting conditions. Moreover, abrupt discontinuation of nitric oxide therapy can lead to severe complications such as declining oxygen levels and an increase in pulmonary artery pressure, necessitating careful administration and monitoring.
Despite its complexities, the NOXBOX® I PLUS system and NOXIVENT must be solely utilized in accordance with the detailed indications, warnings, contraindications, and instructions outlined in the nitric oxide drug labeling. As Linde aims to enhance the life-saving capabilities of its products, detailed safety guidelines can be accessed via their official website.
Linde Gas & Equipment Inc. prides itself on being a leading supplier of medical gases and therapeutic solutions. The organization supports various healthcare settings, including hospitals and clinics, providing essential medical gases like nitrogen, helium, and oxygen. Their longstanding reputation for quality and service excellence makes them a trusted partner in medical care, as they remain committed to continuous innovation in the healthcare space.
According to Jason Aexel, the Director of Clinical Healthcare at Linde Gas & Equipment Inc., the introduction of the NOXBOX® I PLUS aims to provide healthcare professionals with an efficient, economical, and reliable method to deliver inhaled nitric oxide therapy. This development builds upon the success of their existing NOXBOX®i delivery system, which has been operational in over 40 countries since 2013 and in the U.S. since late 2018, widely employed across numerous healthcare facilities.
The NOXBOX® I PLUS features several enhancements designed to improve its usability. Key modifications include an easier setup process, ergonomic enhancements, and precise controls. These upgrades ensure compatibility with various ventilators, ensuring a better user experience for healthcare providers.
Aexel expressed enthusiasm for the potential to gain 510(k) clearance for this updated system, emphasizing Linde's ongoing dedication to improving nitric oxide therapy technology. The company aims to provide high-quality services and deliver advancements that enhance patient care and safety.
Linde's NOXIVENT (nitric oxide) gas is particularly beneficial for neonates, intended to improve oxygenation and lessen dependence on extracorporeal membrane oxygenation in cases of hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. It is a critical agent used alongside ventilatory support and other relevant medicines for patients that meet specified conditions.
The introduction of the NOXBOX® I PLUS signifies not just a step forward in technology but also highlights Linde's commitment to safety protocols. The company reminds users that NOXIVENT is contraindicated in neonates with specific blood shunting conditions. Moreover, abrupt discontinuation of nitric oxide therapy can lead to severe complications such as declining oxygen levels and an increase in pulmonary artery pressure, necessitating careful administration and monitoring.
Despite its complexities, the NOXBOX® I PLUS system and NOXIVENT must be solely utilized in accordance with the detailed indications, warnings, contraindications, and instructions outlined in the nitric oxide drug labeling. As Linde aims to enhance the life-saving capabilities of its products, detailed safety guidelines can be accessed via their official website.
Linde Gas & Equipment Inc. prides itself on being a leading supplier of medical gases and therapeutic solutions. The organization supports various healthcare settings, including hospitals and clinics, providing essential medical gases like nitrogen, helium, and oxygen. Their longstanding reputation for quality and service excellence makes them a trusted partner in medical care, as they remain committed to continuous innovation in the healthcare space.
Topics Health）
【About Using Articles】
You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.
【About Links】
Links are free to use.