NetworkNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT
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HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, is reporting on financial and operations results for its second quarter 2024, the period that ended June 30, 2024. Highlights of the report include steady progress made toward key clinical and regulatory milestones on its HeartBeam AIMIGo(TM) System, including the 510(k) submission to the U.S. Food and Drug Administration (FDA); the report also noted that the company has completed two presubmission meetings with the FDA regarding the company’s planned 510(k) submission of its 12-lead synthesis software.
“The second quarter of 2024 was highlighted by new data for the validation of HeartBeam AI, our deep-learning technology, and ongoing progress with anticipated regulatory and clinical milestones for the AIMIGo vector technology platform,” said HeartBeam founder and CEO Branislav Vajdic, PhD, in the press release. “Looking ahead, our optimism continues for the FDA’s clearance of the AIMIGo system, and we are on track for the planned second 510(k) submission.
“We are encouraged by our progress in using artificial intelligence with our vector technology, showcasing the potential of our artificial-intelligence program to improve diagnostic accuracy when a patient is outside of a medical facility,” Vajdic continued. “We also see strength in our product-development pipeline, notably an extended wear patch for detecting heart attacks and complex cardiac arrythmias. This market is estimated to reach $4.8 billion by 2030. Interest from large industry players in partnering continues on key aspects of our portfolio. Our long-term vision is to transform the monitoring and detection of cardiac conditions through our vector-based technology. Our unique approach allows us to deliver the smallest, easiest to use, cable-free 12-lead ECG to patients and their physicians in a variety of form factors and unlock actionable insights on a wide range of cardiac conditions.”
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