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.
- Drug:
- OCS™ Heart System
- Announced Date:
- August 4, 2025
- Indication:
- For patients with end-stage lung, heart, and liver failure
Announcement
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.
AI Summary
TransMedics Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its Investigational Device Exemption (IDE), clearing the way for the company’s Next-Generation OCS ENHANCE Heart trial. This two-part study will use the Organ Care System (OCS) Heart platform to test prolonged heart perfusion in Part A and compare OCS perfusion to standard cold storage in donation after brain death (DBD) cases in Part B. With over 650 patients planned, it is expected to become the largest heart preservation trial worldwide.
Part B will include DBD hearts not currently eligible for OCS perfusion, with the goal of expanding future clinical indications. TransMedics plans to start enrolling patients in the fourth quarter of 2025, and full trial details will be posted on clinicaltrials.gov. Company leaders view the ENHANCE Heart trial as a key step toward broader clinical adoption in 2026 and beyond, aiming to improve organ quality, increase transplant success, and reset the standard of care for heart transplantation.
Read Announcement
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
FDA Event Stage Terminology & Abbreviation Guide
- 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 8/27/2025 by MarketBeat.com Staff
MarketBeat All Access