Inspira seeks AMAR approval for new oxygenation device

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RA’ANANA, Israel – Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN, IINNW), a medical technology company, has submitted its innovative blood oxygenation device, the INSPIRA™ ART100, to the Israeli Ministry of Health’s medical device regulation unit (AMAR) for approval. This submission is a strategic step in the company’s plan to enter the Southeast Asia and South American markets.

The INSPIRA™ ART100 is the first in a series of devices from Inspira aimed at improving respiratory treatments. The company’s Chief Executive Officer, Dagi Ben-Noon, expressed pride in reaching this significant milestone. The submission is seen as a precursor to the introduction of their second-generation device, the INSPIRA™ ART (Gen 2), which is designed to treat patients while they are awake, potentially eliminating the need for mechanical ventilation.

Inspira’s ART (Gen 2) device employs adaptive blood oxygenation technology, which allows for real-time measurement of blood parameters and the delivery of the required oxygen volume directly into the blood. This technology aims to reduce complications associated with traditional ventilation methods and shorten hospital stays.

The device represents the culmination of extensive research and development efforts by Inspira and is intended to offer a less invasive and more effective treatment option compared to traditional mechanical ventilation. It is designed to enhance oxygenation, reduce the need for intubation, and improve patient outcomes.

Inspira Technologies has developed its Augmented Respiration Technology (INSPIRA ART) with the goal of rebalancing patient oxygen saturation levels, allowing patients to remain awake during treatment, and reducing reliance on invasive mechanical ventilation systems. However, it is important to note that the company’s products have not yet been tested or used in humans and have not received approval from any regulatory entity.

The submission to AMAR is a crucial step for Inspira as it seeks to expand its market presence and offer its technologies to a broader audience. This information is based on a press release statement from Inspira Technologies.

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