HeartBeam Inc. BEAT Archives

WednesdayDec 10, 2025 9:10 am

QualityStocksNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Secures FDA 510(k) Clearance for 12-Lead ECG Synthesis Software Following Successful Appeal

HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through personalized insights, received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment after successfully appealing a prior NSE determination. The patented cable-free technology captures cardiac electrical signals in three non-coplanar dimensions to generate a synthesized 12-lead ECG that can be reviewed remotely by a board-certified cardiologist, enabling patients to capture meaningful ECG data wherever symptoms occur. With clearance in hand, HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups, alongside advancing programs in heart attack detection, development of an on-demand…

MondayDec 01, 2025 9:15 am

QualityStocksNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Outlines Regulatory Strategy After NSE Decision on ECG Synthesis Software

HeartBeam (NASDAQ: BEAT), a medical technology company developing personalized cardiac-care insights, detailed its strategy following receipt of a Not Substantially Equivalent decision for its 510(k) submission covering its 12-lead ECG Synthesis Software. The Company has been in active discussions with FDA review staff, which have signaled willingness to work toward a constructive resolution. HeartBeam said its VALID-ECG clinical study met endpoints and that remaining FDA concerns may be resolved through revised labeling. To advance the process, the Company plans to pursue multiple parallel paths—including a formal appeal or a 510(k) resubmission—and believes recent interactions indicate a viable path forward under…

WednesdayNov 19, 2025 12:50 pm

QualityStocksNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Poised in the Future of Cardiac Care with Breakthrough Technology

HeartBeam (NASDAQ: BEAT) is on the verge of transforming how atrial fibrillation (“AF”) is detected and managed with its cable-free ECG technology. A recent article discussing this reads, “HeartBeam has developed a credit card-sized device and proprietary synthesis software that can capture heart signals in three dimensions and convert them into a full synthesized 12-lead ECG. By bringing clinical -grade cardiac diagnostics into the hands of patients wherever they are, HeartBeam is positioning itself at the forefront of a revolution in heart health, one that could greatly impact lives, reduce costs, and redefine the future of cardiac care.” To view…

FridayNov 14, 2025 9:10 am

QualityStocksNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Reports Q3 2025 Results as FDA Review Nears Completion and Commercial Readiness Accelerates

HeartBeam (NASDAQ: BEAT) reported third-quarter 2025 results and highlighted continued progress toward commercialization of its 12-lead ECG synthesis software, now in the final stage of FDA 510(k) review with anticipated clearance by year end. The company is advancing commercial readiness, including a new partnership with HeartNexus for 24/7 cardiologist review services, alongside new scientific data presented at AHA Scientific Sessions and HRX Live 2025 and an expanded global IP portfolio of 24 issued patents. For the quarter, R&D expenses were $3.3 million, G&A expenses were $2.0 million, net loss was $5.3 million and cash totaled $1.9 million. HeartBeam will discuss…

ThursdayNov 13, 2025 11:15 am

HeartBeam Inc. (NASDAQ: BEAT) Advances Remote Cardiac Diagnostics with HeartNexus Partnership

Cardiovascular disease remains the leading cause of mortality worldwide, responsible for an estimated 17.9 million deaths annually. The HeartBeam System enables a patient to capture a 30-second ECG recording with its credit-card-sized, cable-free device, regardless of where they are. The HeartBeam-HeartNexus collaboration makes board-certified cardiologists available 24/7 to interpret the results for arrhythmia assessment and provide expert feedback directly to the patient or to a coordinating clinician. HeartBeam (NASDAQ: BEAT), a medical-technology company developing next-generation cardiac diagnostics via its patented 12-Lead ECG synthesis software, has announced a strategic collaboration with HeartNexus (https://ibn.fm/yyz1i). The partnership will expand access to cardiologist-level ECG insights for…

TuesdayNov 11, 2025 9:45 am

HeartBeam Inc. (NASDAQ: BEAT) Recognized as a Top Global Innovator in Portable ECG Technology

The company was ranked second worldwide out of 243 companies evaluated in 12-lead ECG innovation in PatentVest’s “Total Cardiac Intelligence” report. HeartBeam’s ranking underscores the rapid maturation of the company’s proprietary synthesis-ECG system. HeartBeam’s intellectual-property foundation is a major reason for its placement. HeartBeam (NASDAQ: BEAT), a medical-technology company developing advanced electrocardiogram solutions for remote cardiac care, has been recognized as a Global IP and Technology Leader in Portable Cardiac Diagnostics by PatentVest’s “Total Cardiac Intelligence” report (https://ibn.fm/ZuLCr). The company ranked second worldwide in 12-lead ECG innovation among 243 firms analyzed, trailing only GE Healthcare. The recognition highlights HeartBeam’s growing influence in…

ThursdayNov 06, 2025 9:00 am

HeartBeam Inc. (NASDAQ: BEAT) Advances Toward Commercialization of Groundbreaking ECG System

ECG data is necessary for the diagnosis of all cardiac arrhythmias in order to assess severity, implications and treatment options. HeartBeam is reporting that its 12-lead ECG synthesis software for arrhythmia assessment has been submitted to the U.S. Food and Drug Administration for 510(k) clearance. To enable smooth commercialization, the company is building the infrastructure needed to support widespread adoption. In the world of heart health, palpitations are common, with atrial fibrillation (“AF”) being one of the most typical sustained arrhythmias in adults (https://ibn.fm/8TSNY). HeartBeam (NASDAQ: BEAT) is on the verge of transforming how AF is detected and managed with…

WednesdayNov 05, 2025 9:00 am

QualityStocksNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Initiated With Buy Rating and $4 Price Target by Roth Capital

HeartBeam (NASDAQ: BEAT) has been initiated with a Buy rating and $4 price target by Roth Capital Partners, which highlighted the company’s near-term catalyst of expected FDA clearance for its groundbreaking 12-lead ECG synthesis software. The report cites BEAT’s compact, credit card-sized, cable-free device capable of synthesizing a full 12-lead ECG as a breakthrough in remote cardiac monitoring. Roth’s analysts, led by Kyle Bauser, Ph.D., view BEAT as undervalued given its strong clinical validation, lean cost structure, and potential to redefine how arrhythmias are detected and treated in decentralized care environments. Roth’s initiation notes that HeartBeam’s pivotal VALID-ECG study (n=198)…

TuesdayOct 28, 2025 10:25 am

QualityStocksNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Partners with HeartNexus to Deliver 24/7 Remote Cardiology Services and Real-Time ECG Interpretation

HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through personalized insights, today announced a partnership with HeartNexus Inc., a network of board-certified cardiologists specializing in cardiac test interpretation, peer consultations, and telemedicine visits. The collaboration enables HeartBeam to offer 24/7 cardiology reader services for patients experiencing cardiac symptoms outside traditional care settings. Using HeartBeam’s patented 3D technology, patients can capture a 30-second, cable-free ECG recording anytime symptoms occur, transmitting the data to HeartNexus cardiologists for immediate interpretation. “Working with HeartNexus accelerates our mission to make medical-grade cardiac monitoring accessible beyond the walls of a medical facility,”…

ThursdayOct 16, 2025 1:52 pm

QualityStocksNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Combining Portability and Precision to Redefine Future of Cardiac Care

HeartBeam (NASDAQ: BEAT) was featured in a recent article that discussed its development of a portable, credit-card-sized device and proprietary software capable of capturing heart signals in three non-coplanar dimensions and reconstructing those signals into a full synthesized 12-lead ECG. “The importance of such innovation is underscored by the widespread impact of heart disease, such as heart rhythm problems… The VALID-ECG study results carry significant weight for both clinical adoption and HeartBeam’s commercialization pathway,” reads the article. “For HeartBeam, the upcoming commercialization of its ECG system represents more than a regulatory milestone; it is a potential step toward redefining how heart…

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