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TransMedics Group (TMDX) FDA Approvals

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TransMedics Group's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by TransMedics Group (TMDX). Over the past two years, TransMedics Group has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as OCS™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

OCS™ Heart System FDA Regulatory Events

OCS™ Heart System is a drug developed by TransMedics Group for the following indication: For patients with end-stage lung, heart, and liver failure. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TransMedics Group FDA Events - Frequently Asked Questions

As of now, TransMedics Group (TMDX) has not received any FDA approvals for its therapy in the last two years.

In the past two years, TransMedics Group (TMDX) has reported FDA regulatory activity for OCS™ Heart System.

The most recent FDA-related event for TransMedics Group occurred on August 4, 2025, involving OCS™ Heart System. The update was categorized as "Conditional approval," with the company reporting: "TransMedics Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its Investigational Device Exemption (IDE), allowing the company to proceed with the initiation of its Next-Generation OCS ENHANCE Heart trial."

Currently, TransMedics Group has one therapy (OCS™ Heart System) targeting the following condition: For patients with end-stage lung, heart, and liver failure.

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:TMDX) was last updated on 8/6/2025 by MarketBeat.com Staff
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