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.
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.
- Drug:
- AIMIGo™
- Announced Date:
- May 13, 2024
- Indication:
- Device study
Announcement
HeartBeam, Inc announced that HeartBeam AIMIGo™ has been selected as winner of the "Best New ECG Technology Solution" award in the 8th annual MedTech Breakthrough Awards program.
Read Announcement
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.
- Drug:
- HeartBeam system
- Announced Date:
- December 16, 2024
- Indication:
- For comprehensive arrhythmia assessment.
Announcement
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..
AI Summary
HeartBeam, Inc recently announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its innovative HeartBeam system, which is designed for comprehensive arrhythmia assessment. This clearance means that the HeartBeam system has met the FDA’s safety and effectiveness standards. The technology can help healthcare providers quickly and accurately detect irregular heart rhythms, leading to more timely and effective treatment. Clinicians now have a new tool that combines modern digital monitoring with established diagnostic practices.
The approval of this system is an important step forward for both patients and medical professionals. With enhanced heart monitoring capabilities, the HeartBeam system could improve patient care by offering a more efficient way to assess and manage arrhythmias. This milestone demonstrates ongoing advances in medical technology that aim to better support early detection and treatment of heart conditions.
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