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HeartBeam Charts FDA Path After 12-Lead ECG Software Decision

HeartBeam details FDA strategy for 12-lead ECG software after Not Substantially Equivalent decision. Company pursuing appeal path for breakthrough cardiac monitoring technology.

This development matters because it represents a critical juncture for innovative cardiac monitoring technology that could revolutionize how heart conditions are detected and managed. HeartBeam's 3D ECG technology promises to move cardiac care beyond traditional clinical settings, enabling remote monitoring that could catch life-threatening conditions earlier and reduce healthcare costs. The FDA's engagement with the company suggests regulatory pathways exist for this breakthrough technology, which has already shown clinical success. For patients with cardiac conditions, this could mean more accessible, continuous monitoring that doesn't require frequent clinic visits. For the healthcare system, it represents a shift toward preventive, data-driven cardiac care that could reduce emergency room visits and hospitalizations. The company's progress also signals broader trends in digital health innovation and regulatory adaptation to new medical technologies.