TransMedics erhält vollständige FDA-IDE-Zulassung für OCS Heart ENHANCE Trial

Reuters
Yesterday
TransMedics erhält vollständige FDA-IDE-Zulassung für OCS Heart ENHANCE Trial

TransMedics Group Inc. hat die vollständige und uneingeschränkte Genehmigung der US-amerikanischen Food and Drug Administration (FDA) für die Investigational Device Exemption $(IDE)$ der Next-Generation OCS Heart ENHANCE-Studie erhalten. Zuvor hatte das Unternehmen im Januar 2026 die vollständige FDA-Genehmigung für die Next-Generation OCS DENOVO Lung IDE-Studie und im August 2025 eine bedingte IDE-Genehmigung für die ENHANCE Heart-Studie erhalten.

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