NasdaqGM:TMDXMedical Equipment
How Investors May Respond To TransMedics Group (TMDX) Full IDE Approval For ENHANCE Heart Trial
In early February 2026, TransMedics Group, Inc. received full U.S. FDA approval for its Investigational Device Exemption for the Next-Generation OCS ENHANCE Heart trial, advancing a two-part study designed to support prolonged heart perfusion and compare OCS Heart with traditional static cold storage in brain-dead donor cases.
This full IDE approval, following recent green lights for the company’s next-generation lung trial, highlights regulatory momentum behind its organ care platform and...