Adagio Medical's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Adagio Medical (ADGM).
Over the past two years, Adagio Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
FULCRUM-VT. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
FULCRUM-VT FDA Regulatory Timeline and Events
FULCRUM-VT is a drug developed by Adagio Medical for the following indication: for Ventricular Tachycardia.
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:
- FULCRUM-VT
- Announced Date:
- April 26, 2026
- Indication:
- for Ventricular Tachycardia
Announcement
Adagio Medical Holdings, Inc today reported six month results from its FULCRUM-VT Investigational Device Exemption ("IDE") clinical trial, which will be used to support the Company's application for Food and Drug Administration ("FDA") Premarket Approval of the vCLAS Ventricular Ablation System.
AI Summary
Adagio Medical reported six‑month results from its pivotal FULCRUM‑VT IDE trial, which will support its application for FDA Premarket Approval of the vCLAS Ventricular Ablation System. At six months, patients experienced 84% freedom from shock and 59% freedom from ventricular tachycardia (VT) recurrence. Those outcomes met the trial’s safety and effectiveness endpoints and replicated results seen in the earlier CryoCure‑VT study.
The data also showed the vCLAS system delivered equivalent effectiveness for both ischemic and non‑ischemic cardiomyopathy using an endocardial approach, a notable finding for ablation therapy. Adagio’s vCLAS cryoablation technology is already commercially available in Europe and some other regions, but remains investigational in the United States as the company pursues FDA approval based on these FULCRUM‑VT results.
Read Announcement- Drug:
- FULCRUM-VT
- Announced Date:
- April 8, 2026
- Indication:
- for Ventricular Tachycardia
Announcement
Adagio Medical Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to expand the Company's FULCRUM-VT trial to evaluate the safety and effectiveness of the Company's next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT).
AI Summary
Adagio Medical Holdings, Inc. said the U.S. Food and Drug Administration has granted an Investigational Device Exemption (IDE) to expand its FULCRUM-VT trial. The expansion will evaluate the safety and effectiveness of the company’s next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System for treating Sustained Monomorphic Ventricular Tachycardia (SMVT). This IDE lets Adagio study the device in patients under a controlled clinical protocol to gather data on outcomes and risks.
The next-generation vCLAS ULTA system is designed to deliver faster, more efficient ablation with improved usability on an established, titratable, endocardial-approach ULTA platform. The trial aims to assess how well the device performs in real-world procedures and whether its design advances translate into better treatment for SMVT. IDE approval is a key step toward potential future regulatory filings and wider clinical use if results show the system is safe and effective.
Read Announcement- Drug:
- FULCRUM-VT
- Announced Date:
- October 1, 2025
- Indication:
- for Ventricular Tachycardia
Announcement
Adagio Medical Holdings, Inc announced the completion of enrollment of the FULCRUM-VT Pivotal U.S. Food and Drug Administration ("FDA") Investigational Device Exemption ("IDE") study evaluating the Company's vCLASTM Cryoablation System ("vCLAS" or "vCLAS System") for ablation of monomorphic ventricular tachycardia (MMVT).
AI Summary
Adagio Medical Holdings announced it has finished enrolling 208 patients in the FULCRUM-VT pivotal IDE study of its vCLAS™ Cryoablation System, a novel ultra-low temperature technology for treating monomorphic ventricular tachycardia (MMVT). This single-arm, multi-center trial across 20 sites in the U.S. and Canada will assess safety and effectiveness for scar-mediated, sustained MMVT in patients with structural heart disease. The main goal is six-month freedom from recurrent MMVT without increasing antiarrhythmic drugs. Study findings will support a pre-market approval application, targeting completion of the PMA process by late 2026. The vCLAS System is already available for MMVT treatment in Europe and select regions but remains investigational in the United States. Adagio plans to use these results to bring its purpose-built cryoablation technology to a large population of VT patients seeking more effective treatment options.
Enrollment took only 11 months, underscoring strong interest in this VT-specific ablation method among leading heart centers.
Read Announcement
Adagio Medical FDA Events - Frequently Asked Questions
As of now, Adagio Medical (ADGM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Adagio Medical (ADGM) has reported FDA regulatory activity for FULCRUM-VT.
The most recent FDA-related event for Adagio Medical occurred on April 26, 2026, involving FULCRUM-VT. The update was categorized as "Results," with the company reporting: "Adagio Medical Holdings, Inc today reported six month results from its FULCRUM-VT Investigational Device Exemption ("IDE") clinical trial, which will be used to support the Company's application for Food and Drug Administration ("FDA") Premarket Approval of the vCLAS Ventricular Ablation System."
Currently, Adagio Medical has one therapy (FULCRUM-VT) targeting the following condition: for Ventricular Tachycardia.
More FDA Event Resources from MarketBeat
Companies With Recent FDA Events
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
FDA progress for NASDAQ:ADGM last updated on 4/27/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
