Inspira Technologies gains key Israeli approval for INSPIRA ART100 system

The INSPIRA ART100 is an extra-corporeal membrane oxygenation and cardiopulmonary bypass system.

Shalini Nair July 12 2024

Inspira Technologies OXY has announced the receipt of the Israeli Ministry of Health's approval for its INSPIRA ART100 system, marking a significant step in the company's efforts to commercialise its medical technology.

The approval from the Israeli Ministry of Health's medical devices and accessories (AMAR) division is for the system's use in extra-corporeal membrane oxygenation and cardiopulmonary bypass procedures.

The Israeli regulatory approval is a pivotal achievement for Inspira Technologies, as it underpins the company's strategy to initiate business development activities to introduce its innovative products to the market.

The endorsement by the Israeli Ministry of Health is seen as a testament to Inspira's ability to navigate the regulatory landscape and secure approvals for its medical devices.

Inspira medical director Dr Dekel Stavi said: "As a physician and the head of the Israeli ECMO Society, I am delighted to witness this exciting milestone where hospitals will have the opportunity to acquire and use the innovative and technologically cutting-edge INSPIRA ART100."

Inspira Technologies CEO Dagi Ben-Noon said: "After we received FDA approval for the INSPIRA ART100 that will allow us to establish our presence in the US, receiving AMAR approval will facilitate the creation of business opportunities in new regions and emerging markets."

Inspira Technologies has previously secured the US Food and Drug Administration (FDA) 510(k) clearance for the INSPIRA ART100 system for cardiopulmonary bypass procedures. The AMAR certification extends this approval for extra-corporeal membrane oxygenation.

While the INSPIRA ART100 system has reached regulatory milestones, the company's other products, such as the INSPIRA ART (Gen 2) and the HYLA blood sensor, are still in development.

Uncover your next opportunity with expert reports

Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.

Newsletters by sectors

close

Sign up to the newsletter: In Brief

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close