HeartBeam to Present Results of ALIGN-ACS Study for Heart Attack Assessment at TCT 2026 on November 1, 2026
Business Wire•28/10/2026•08:31 ET
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Key Highlights
- ➤ALIGN-ACS results scheduled for November 1, 2026, at TCT 2026
- ➤132 patients enrolled across two Belgrade, Serbia, emergency-department sites
- ➤Results will shape HeartBeam’s planned U.S. pivotal study, anticipated Q1 2027
- ➤HeartBeam received FDA Breakthrough Device Designation for heart attack assessment
- ➤HeartBeam entered FDA’s Total Product Life Cycle Advisory Program (TAP)
Expert Statements
Branislav Vajdic, Founder and President of HeartBeam
“Heart attack assessment is our top strategic priority and ALIGN-ACS is a key step in comparing our 3D ECG technology to the standard 12-lead ECG in patients with a suspected heart attack. We look forward to Dr. Nichol’s presentation of the ALIGN-ACS pilot study results at TCT 2026,”
Branislav Vajdic, Founder and President of HeartBeam
“With FDA Breakthrough Device Designation and acceptance into the FDA’s Total Product Life Cycle Advisory Program (TAP) (link) in place, these results will help shape the design of our U.S. pivotal study which we anticipate initiating in first quarter 2027. We look forward to Dr. Nichol’s presentation and to sharing the findings.”
HeartBeam to Present Results of ALIGN-ACS Study for Heart Attack Assessment at TCT 2026 on November 1, 2026
* ALIGN-ACS pilot study compared the HeartBeam 3D ECG technology to a standard 12-lead ECG for detection of acute coronary syndrome (ACS)
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