10:14 AM EDT, 05/28/2024 (MT Newswires) -- Inspira Technologies (IINN) said Tuesday its Inspira ART100 cardiopulmonary bypass system got 510(k) class II clearance from the US Food and Drug Administration.

Other products, including the Inspira ART (Gen 2) and HYLATM blood sensor, haven't yet been tested or used in people and haven't been approved by any regulatory entity, the company said.

Shares of Inspira fell 8.7% in recent Tuesday trading, erasing earlier gains.

Price: 2.00, Change: -0.19, Percent Change: -8.72