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HeartBeam (BEAT) FDA Events

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FDA Events for HeartBeam (BEAT)

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

HeartBeam's Drugs in FDA Review

AIMIGo™ - FDA Regulatory Timeline and Events

AIMIGo™ is a drug developed by HeartBeam for the following indication: Device study. 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.

HeartBeam system - FDA Regulatory Timeline and Events

HeartBeam system is a drug developed by HeartBeam for the following indication: For comprehensive arrhythmia assessment. 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.

HeartBeam FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, HeartBeam (BEAT) has reported FDA regulatory activity for the following drugs: HeartBeam system and AIMIGo™.

The most recent FDA-related event for HeartBeam occurred on December 16, 2024, involving HeartBeam system. The update was categorized as "FDA Clearance," with the company reporting: "HeartBeam, Inc announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance of the HeartBeam system for comprehensive arrhythmia assessment announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance of the HeartBeam system for comprehensive arrhythmia assessment.."

Current therapies from HeartBeam in review with the FDA target conditions such as:

  • For comprehensive arrhythmia assessment. - HeartBeam system
  • Device study - AIMIGo™

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:BEAT) was last updated on 7/9/2025 by MarketBeat.com Staff
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