Inspira Technologies today announced the U.S. Food and Drug Administration listing of its medical cart, the INSPIRAâ„¢ CART, which has been custom designed for use with the INSPIRAâ„¢ ART100 system. Inspira aims to streamline healthcare delivery in a variety of clinical scenarios, transforming the INSPIRAâ„¢ ART100 system into a mobile workstation supporting medical personnel in administering medical care quickly.
The INSPIRAâ„¢ CART is intended for use by medical professionals in U.S. operating rooms during cardiopulmonary bypass procedures. Classified as a Class I Medical Device and 510(K) Exempt under the FDA code for cardiopulmonary bypass accessory equipment, this device's regulatory status underscores its compliance with safety and efficacy standards, facilitating its entry into the U.S. market.
Inspira aims to reshape the respiratory and life-support landscape. The company is developing novel life support-extending technologies with Inspira blood oxygenation and blood monitoring technologies, collectively targeting an estimated combined market opportunity of approximately $59 billion a year.
The company is working to deploy the FDA cleared INSPIRAâ„¢ ART100 system in U.S and Israeli hospitals. The overall strategy is to generate business development activities with potential partners who are aiming to expand their product portfolio in the industry.
The company also offers:
- HYLAâ„¢ blood sensor which is designed to monitor blood parameters continuously and in real-time.
- INSPIRAâ„¢ Cardi-ART is a portable unit designed to oxygenate the brain to support patients undergoing cardiac arrest.
- INSPIRAâ„¢ ART (Gen 2), also known as the INSPIRAâ„¢ ART500, will include the company's adaptive blood oxygenation technology with the HYLAâ„¢ blood sensor. The technology elevates patient oxygen saturation levels in minutes, potentially allowing patients to remain awake during treatment, enabling patients to be treated in and beyond intensive care units.
The INSPIRAâ„¢ ART100 system received FDA 510(k) clearance for cardiopulmonary bypass procedures and AMAR certification for extra-corporeal membrane oxygenation and cardiopulmonary bypass procedures.
The company's other products, including the INSPIRAâ„¢ ART (Gen 2), the INSPIRAâ„¢ Cardi-ART portable modular device and HYLAâ„¢ blood sensor, are currently being designed and developed, and have not yet been tested or used in humans and have not been approved by any regulatory entity.
