HeartBeam Announces FDA Clearance for At-Home, High-Fidelity Heart Monitoring Technology
HeartBeam (NASDAQ: BEAT) has received FDA 510(k) clearance for its innovative cardiac monitoring system. The device is the first cable-free, credit card-sized ECG that captures heart signals from three distinct directions, enabling high-fidelity data collection. When patients experience symptoms, they can use the HeartBeam app to record a 30-second ECG, which is then cloud-processed and sent to physicians for review.
The company plans to launch an Early Access Program and is developing future advances including: synthesized 12-lead ECG capabilities, AI-based classification algorithms for improved arrhythmia detection, and heart attack detection features. A study in JACC: Advances demonstrated the technology's high accuracy (95% AUC) in identifying coronary occlusions, comparable to standard 12-lead ECGs.
HeartBeam (NASDAQ: BEAT) ha ricevuto l'autorizzazione FDA 510(k) per il suo innovativo sistema di monitoraggio cardiaco. Il dispositivo è il primo ECG di dimensioni simili a una carta di credito, senza cavi, che cattura i segnali cardiaci da tre direzioni distinte, consentendo una raccolta dati ad alta fedeltà. Quando i pazienti avvertono sintomi, possono utilizzare l'app HeartBeam per registrare un ECG di 30 secondi, che viene poi elaborato nel cloud e inviato ai medici per la revisione.
La società prevede di lanciare un programma di accesso anticipato e sta sviluppando futuri miglioramenti che includono: capacità di ECG sintetizzati a 12 derivazioni, algoritmi di classificazione basati sull'IA per un rilevamento migliorato delle aritmie e funzionalità per la rilevazione dell'infarto. Uno studio pubblicato su JACC: Advances ha dimostrato l'alta accuratezza della tecnologia (95% AUC) nell'identificazione delle occlusioni coronariche, paragonabile agli ECG standard a 12 derivazioni.
HeartBeam (NASDAQ: BEAT) ha recibido la aprobación 510(k) de la FDA para su innovador sistema de monitoreo cardíaco. El dispositivo es el primer ECG sin cables y del tamaño de una tarjeta de crédito que capta señales del corazón desde tres direcciones distintas, lo que permite una recopilación de datos de alta fidelidad. Cuando los pacientes experimentan síntomas, pueden usar la aplicación HeartBeam para registrar un ECG de 30 segundos, que luego se procesa en la nube y se envía a los médicos para su revisión.
La compañía planea lanzar un programa de Acceso Anticipado y está desarrollando futuros avances que incluyen: capacidades de ECG sintetizadas de 12 derivaciones, algoritmos de clasificación basados en IA para mejorar la detección de arritmias y funciones para la detección de infartos. Un estudio en JACC: Advances demostró la alta precisión de la tecnología (95% AUC) para identificar oclusiones coronarias, comparable a los ECG estándar de 12 derivaciones.
HeartBeam (NASDAQ: BEAT)는 혁신적인 심장 모니터링 시스템에 대해 FDA 510(k) 승인을 받았습니다. 이 장치는 심장 신호를 세 방향에서 포착할 수 있는 최초의 무선 카드 크기 ECG로, 고충실도 데이터 수집을 가능하게 합니다. 환자가 증상을 경험할 때, HeartBeam 앱을 사용하여 30초 ECG를 기록할 수 있으며, 이 데이터는 클라우드에서 처리되어 의사에게 검토를 위해 전송됩니다.
회사는 조기 접근 프로그램을 출시할 계획이며, 미래 발전을 위해 12유도 ECG 기능 합성, 향상된 부정맥 탐지를 위한 AI 기반 분류 알고리즘, 및 심장 발작 탐지 기능 등을 개발하고 있습니다. JACC: Advances에 발표된 연구는 관상 동맥 폐색을 식별하는 데 있어 기술의 높은 정확성을 보여주었으며(95% AUC), 표준 12유도 ECG와 비교할 수 있습니다.
HeartBeam (NASDAQ: BEAT) a reçu l'approbation FDA 510(k) pour son système de surveillance cardiaque innovant. L'appareil est le premier ECG sans fil de la taille d'une carte de crédit qui capture les signaux cardiaques de trois directions distinctes, permettant une collecte de données de haute fidélité. Lorsque les patients ressentent des symptômes, ils peuvent utiliser l'application HeartBeam pour enregistrer un ECG de 30 secondes, qui est ensuite traité dans le cloud et envoyé aux médecins pour examen.
L'entreprise prévoit de lancer un programme d'accès anticipé et développe de futures avancées, y compris : des capacités d'ECG synthétisées à 12 dérivations, des algorithmes de classification basés sur l'IA pour améliorer la détection des arythmies et des fonctionnalités de détection d'infarctus. Une étude publiée dans JACC : Advances a démontré la haute précision de la technologie (95 % AUC) dans l'identification des occlusions coronaires, comparable aux ECG standards à 12 dérivations.
HeartBeam (NASDAQ: BEAT) hat die FDA 510(k)-Zulassung für sein innovatives Herzüberwachungssystem erhalten. Das Gerät ist das erste kabellose, kreditkarten-große EKG, das Herzsignale aus drei unterschiedlichen Richtungen erfasst, was eine hochpräzise Datensammlung ermöglicht. Wenn Patienten Symptome verspüren, können sie die HeartBeam-App verwenden, um ein 30-sekündiges EKG aufzuzeichnen, das dann in der Cloud verarbeitet und zur Überprüfung an Ärzte gesendet wird.
Das Unternehmen plant die Einführung eines Frühzugangsprogramms und entwickelt zukünftige Fortschritte, die unter anderem folgende Punkte umfassen: synthetisierte 12-Kanal EKG-Funktionen, KI-basierte Klassifikationsalgorithmen zur Verbesserung der Arrhythmieerkennung und Funktionen zur Erkennung von Herzinfarkten. Eine Studie in JACC: Advances hat eine hohe Genauigkeit der Technologie (95% AUC) bei der Identifizierung von koronaren Okklusionen gezeigt, die mit den Standard 12-Kanal EKGs vergleichbar ist.
- Received FDA 510(k) clearance for comprehensive arrhythmia assessment
- First-of-its-kind cable-free, credit card-sized ECG device
- Technology demonstrated 95% accuracy in identifying coronary occlusions
- AI algorithm outperformed cardiologists in detecting certain arrhythmias
- None.
Insights
The FDA 510(k) clearance for HeartBeam's novel ECG device represents a significant technological breakthrough in ambulatory cardiac monitoring. The device's unique ability to capture ECG signals from three directions in a credit card-sized form factor addresses a critical gap in remote cardiac monitoring. The cable-free design and immediate data transmission capabilities could significantly reduce the time-to-treatment for cardiac events.
The technology's planned evolution to include synthesized 12-lead ECG capabilities and AI-based classification algorithms positions it well in the growing digital health market. With a
This FDA clearance positions HeartBeam strategically in the rapidly growing cardiac monitoring market. The planned Early Access Program will be important for gathering real-world feedback and refining the commercialization strategy. The company's market timing is optimal, given the increasing adoption of remote patient monitoring technologies and the growing emphasis on preventive cardiac care.
With a market cap of
- First cable-free, ambulatory ECG that captures the heart’s electrical signals from three distinct directions for high-fidelity data collection and advanced diagnostics
- Patients can have the credit card-sized device with them at all times, ready to record an ECG whenever they feel symptoms and reduce delays in care
- Company to initiate Early Access Program to gain important patient and physician feedback on the use of the system in preparation for commercial launch
When a patient feels symptoms, the HeartBeam patient app guides them through the process of placing the device on their chest and capturing a 30-second recording. Once a recording is taken, the signals are sent to the cloud, processed and sent to a physician for review. The physician reviews the ECG recording in the context of the patient’s symptoms and medical history, then follows up with the patient on next steps. The Company plans to initiate an Early Access Program and is creating a waitlist of interested patients and physicians.
To Join the Waitlist, Sign Up Here
Watch a Video of How the HeartBeam System Works
“It’s well documented that patients who delay seeking care for their cardiac symptoms face worse clinical outcomes. The ability for patients to capture high-fidelity ECG signals from three directions wherever they are when symptoms occur will help patients get the care they need in a timelier manner,” said Robert Eno, Chief Executive Officer, HeartBeam. “The FDA clearance of our technology is a significant milestone for the Company that brings us one step closer to fulfilling our vision of providing unprecedented cardiac insights to individuals and physicians.”
The FDA clearance is foundational and will serve as the basis for future submissions as the Company strives to simplify the access of intelligent and actionable 12-lead ECGs for both patients and physicians. Future planned advances include:
- Synthesized 12-lead ECG: The HeartBeam system is designed to be capable of synthesizing the heart’s signals collected from three directions into a 12-lead ECG using a personalized transformation matrix as demonstrated in this pilot study.
- AI-Based Classification Algorithms: Data presented earlier this year demonstrated that HeartBeam’s deep learning algorithm has the potential to greatly improve the detection of atrial flutter, even outperforming cardiologists in detecting some arrhythmias.
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Heart Attack Detection: A study published in JACC: Advances showed that HeartBeam’s ambulatory technology is comparable to a standard 12-lead ECG in identifying coronary occlusions and is highly accurate (Area Under the Curve of
95% ). Another feasibility study highlighted the potential of HeartBeam’s technology to calculate a heart attack risk-score to assess chest pain remotely.
HeartBeam's proprietary technology has the potential to unlock valuable diagnostic and predictive insights. The ease of collecting higher-fidelity ECG signals will enable patients to gather a series of recordings over time. The Company aims to leverage AI to analyze this rich set of data, delivering a longitudinal view of a patient’s cardiac health and predicting cardiac conditions before symptoms appear. HeartBeam believes its groundbreaking technology presents a transformative opportunity to bring about a paradigm shift in cardiovascular care for millions of patients globally.
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first ever cable-free synthesized 12-lead ECG capable of capturing the heart’s electrical signals from three distinct directions. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. The Company holds 13 US and 4 international issued patents related to technology enablement. For additional information, visit HeartBeam.com.
About the HeartBeam System
The HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional. For full safety information, see the full Instructions for Use or Clinician Portal Manual.
Forward-Looking Statements
All statements in this release that are not based on historical fact are "forward-looking statements." While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Forms 10-K, 10-Q and other reports filed with the SEC and available at www.sec.gov. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
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Investor Relations Contact:
Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
BEAT@mzgroup.us
www.mzgroup.us
Media Contact:
media@heartbeam.com
Source: HeartBeam, Inc.
FAQ
What features does HeartBeam's (BEAT) FDA-cleared cardiac monitoring device offer?
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What future developments is HeartBeam (BEAT) planning for its cardiac monitoring system?
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