Inspira Technologies Oxy B.H.N. Ltd. (IINN) announced on Tuesday that its cardiopulmonary bypass system, ART100, has gained 510(k) clearance from the U.S. Food and Drug Administration (FDA).
The medical technology firm stated that the ART100 is designed for use in an extracorporeal perfusion circuit to pump blood during cardiopulmonary bypass procedures lasting up to six hours.
At present, Inspira's stock is experiencing a decline of 8.9%, trading at $2 on the Nasdaq.
