HeartBeam Receives FDA Breakthrough Device Designation for Heart Attack Assessment
Key Highlights
- ➤FDA grants HeartBeam System Breakthrough Device Designation for heart attack assessment
- ➤Designation provides prioritized FDA interaction toward a pivotal multicenter study
- ➤Breakthrough status positions HeartBeam to pursue expedited Medicare coverage pathways
- ➤HeartBeam expects pivotal-study design alignment and patient enrollment in coming months
- ➤ALIGN-ACS pilot included 134 patients; TCT and HEADSTART-ACS updates expected soon
Expert Statements
Tony Das, M.D., Cardiologist and HeartBeam scientific advisory board member
“One of the biggest gaps in heart attack care today occurs before the patient ever arrives at the hospital. While hospital systems have significantly improved time to treatment inside medical facilities, patients often still delay seeking care because symptoms can be subtle or easily dismissed”
Tony Das, M.D., Cardiologist and HeartBeam scientific advisory board member
“HeartBeam’s technology has the potential to address this gap by providing timely access to clinical-grade ECG data outside the hospital, which could enable earlier MI intervention.”
Branislav Vajdic, PhD, Founder and President of HeartBeam
“Receiving Breakthrough Device Designation is an important milestone for our heart attack detection program”
Branislav Vajdic, PhD, Founder and President of HeartBeam
“With heart attack detection now clearly established as HeartBeam’s top strategic priority, the progress across our regulatory, clinical and development programs points to increasing momentum and an accelerating path forward. This designation deepens our engagement with the FDA as we work toward alignment on our pivotal study and positions us to pursue an expedited path to Medicare coverage. Both are critical steps toward our goal of giving physicians objective ECG information when heart attack symptoms begin, potentially helping patients seek appropriate care sooner.”
HeartBeam Receives FDA Breakthrough Device Designation for Heart Attack Assessment
* Designation recognizes the potential of HeartBeam’s 3D ECG technology to help physicians assess suspected heart attacks outside the hospital * Breakthrough status provides prioritized FDA interaction as HeartBeam advances toward a pivotal study * Designation positions HeartBeam to pursue an expedited Medicare coverage pathway * Updates on ALIGN-ACS data at TCT and the HEADSTART-ACS study expected in coming weeks HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the HeartBeam System as a tool for assessing potential heart attacks at home.
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