Free Trial

iRhythm Technologies (IRTC) FDA Events

iRhythm Technologies logo
$132.88 -1.75 (-1.30%)
Closing price 07/9/2025 04:00 PM Eastern
Extended Trading
$133.16 +0.28 (+0.21%)
As of 04:05 AM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
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.

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

  • 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
From Our Partners