Inspira Technologies nears FDA 510(k) clearance for ART device

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Inspira Technologies nears FDA 510(k) clearance for ART device
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RA'ANANA, Israel - Inspira Technologies OXY B.H.N. Ltd. ( NASDAQ :IINN) (NASDAQ:IINNW), a medical technology company, announced it is advancing towards obtaining 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its INSPIRA™ ART100 device. The company anticipates the clearance within the first half of 2024 and has plans for additional FDA submissions in the coming years.

The INSPIRA™ ART100 is a medical device designed to improve oxygenation in patients, potentially reducing the need for mechanical ventilation, which can be invasive and risky. Alongside this development, Inspira Technologies has secured three patents from the United States Patent and Trademark Office (USPTO) for its core technologies, with three more applications pending.

Inspira Technologies has also reported signing summary distribution agreements valued at $546 million, conditional on regulatory approvals and authorizations. These agreements are part of a strategic plan to impact the $19 billion mechanical ventilator market with its INSPIRA™ ART device, which incorporates adaptive blood oxygenation technology.

The company's proprietary HYLA blood sensor and VORTX™, an orbiting blood oxygenation delivery system, are key components of the INSPIRA™ ART device. This system is designed to scan blood parameters in real-time and deliver the required oxygen volume directly into the patient's bloodstream.

Joe Hayon, President and Co-founder of Inspira Technologies, expressed confidence in the role of the HYLA blood sensor and the potential of the INSPIRA™ ART device to transform patient treatment by delivering oxygen directly into the blood.

Inspira Technologies emphasizes that its products have not yet been tested or used in humans and are pending approval from regulatory entities. The company's forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially.

The information in this article is based on a press release statement from Inspira Technologies.

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