FDA Events for iRhythm Technologies (IRTC)
This section highlights FDA-related milestones and regulatory updates for drugs developed by iRhythm Technologies (IRTC).
Over the past two years, iRhythm Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
GUARD-AF. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
GUARD-AF - FDA Regulatory Timeline and Events
GUARD-AF is a drug developed by iRhythm Technologies for the following indication: To evaluate the impact of screening for undiagnosed atrial fibrillation (AF).
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:
- GUARD-AF
- Announced Date:
- September 1, 2024
- Indication:
- To evaluate the impact of screening for undiagnosed atrial fibrillation (AF)
Announcement
iRhythm Technologies, Inc. announced the presentation and publication of the GUARD-AF (ReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals) randomized clinical trial at the European Society of Cardiology (ESC) Congress 2024.
AI Summary
iRhythm Technologies, Inc. announced the presentation and publication of the GUARD-AF trial at the ESC Congress 2024. This study is the largest randomized trial in a primary care setting to evaluate screening for undiagnosed atrial fibrillation (AF) using their Zio® XT patch for long-term continuous monitoring.
The trial involved over 11,900 patients aged 70 and above and compared screening with the Zio® XT patch to usual care. Patients using the patch had a higher detection rate of AF (5.0% vs. 3.3%). Although the study did not show a significant reduction in stroke hospitalizations, it demonstrates that early AF detection in primary care is possible and could improve overall heart care through earlier intervention. The findings underscore the potential benefits of home-based cardiac monitoring for older adults.
Read Announcement
iRhythm Technologies FDA Events - Frequently Asked Questions
As of now, iRhythm Technologies (IRTC) has not received any FDA approvals for its therapy in the last two years.
In the past two years, iRhythm Technologies (IRTC) has reported FDA regulatory activity for GUARD-AF.
The most recent FDA-related event for iRhythm Technologies occurred on September 1, 2024, involving GUARD-AF. The update was categorized as "Publication," with the company reporting: "iRhythm Technologies, Inc. announced the presentation and publication of the GUARD-AF (ReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals) randomized clinical trial at the European Society of Cardiology (ESC) Congress 2024."
Currently, iRhythm Technologies has one therapy (GUARD-AF) targeting the following condition: To evaluate the impact of screening for undiagnosed atrial fibrillation (AF).
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:IRTC) was last updated on 7/10/2025 by MarketBeat.com Staff
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