HeartBeam, Inc. (BEAT) is having quite a Wednesday. Shares rocketed higher by more than 75% as trading volume exploded—193.38 million shares changed hands compared to the usual 2.19 million. The catalyst? FDA clearance that could reshape how people monitor their heart rhythm from home.

The U.S. Food and Drug Administration granted 510(k) clearance for HeartBeam's 12-lead electrocardiogram synthesis software, specifically for assessing arrhythmias. If you're not familiar, arrhythmias are basically when your heart decides to improvise its rhythm—beating too fast (tachycardia), too slow (bradycardia), or just going rogue with an irregular pattern.

This clearance is particularly sweet for HeartBeam because it comes after the company successfully appealed an earlier Not Substantially Equivalent determination from the FDA. Persistence pays off.

Here's what makes HeartBeam's technology interesting: unlike those single-lead or 6-lead consumer devices you might wear on your wrist, HeartBeam's patented cable-free system captures your heart's electrical signals in three non-coplanar dimensions. Think of it as getting a 3D picture instead of a flat snapshot. The software then synthesizes this data into a full 12-lead ECG representation—the gold standard that cardiologists actually want to see.

The practical upside? Patients can get a comprehensive ECG reading for their arrhythmia from home, or really anywhere they happen to be when symptoms strike. No cables, no clinic visit required. The synthesized 12-lead ECG gets promptly reviewed by an on-demand, board-certified cardiologist.

Now that they've got FDA clearance, HeartBeam is mapping out some ambitious growth plans:

Limited Launch in Early 2026: The company plans a targeted rollout to select concierge and preventive cardiology practices that have already expressed strong interest. This controlled introduction should validate real-world performance and establish reference sites before broader commercialization.

Heart Attack Detection Pathway: HeartBeam will pursue an additional indication for detecting heart attacks, backed by promising proof-of-concept data. Management sees this as a major expansion opportunity that could potentially reach tens of millions of U.S. patients.

Extended-Wear 12-Lead Patch: The company is advancing its on-demand 12-lead ECG extended-wear patch, now at the working-prototype stage. This platform targets a multi-billion-dollar reimbursable market and could offer best-in-class capabilities.

Longitudinal Data and AI: As adoption scales, HeartBeam aims to leverage the data-rich output of its 3D ECG technology. Continuous patient-generated 12-lead ECG records could enable AI-driven screening and predictive tools that go beyond what traditional wearables or single-timepoint ECGs can offer.

The initial U.S. commercial launch is scheduled for the first quarter of 2026, focusing on concierge and preventive cardiology practices that have already signaled strong adoption interest.

At last check Wednesday, BEAT stock was trading at $1.42, up 75.73% for the session.