SafeBeat Rx App

by SafeBeat Rx, Inc.  · Based in United States → — AI-powered support for safe pharmacological treatment and monitoring of cardiac arrhythmias.
Cardiology Critical Care Emergency Medicine

Regulatory Status Disclosed

Overview

The SafeBeat Rx App is an AI-powered medical tool developed by SafeBeat Rx, Inc. that focuses on cardiac care workflows, particularly ECG analysis and remote therapeutic monitoring. It is designed to assist clinicians in assessing patient information and guiding cardiac care.

  • What it does: The SafeBeat Rx App utilizes proprietary machine learning algorithms for ECG interpretation and to provide treatment management recommendations. It aims to streamline the process of remote therapeutic monitoring by integrating with third-party FDA-cleared cardiac monitoring devices, such as mobile ECGs, mobile cardiac telemetry, and implantable cardiac monitors. The app also includes explainable AI and custom tools to display diagnostic information and patient-specific treatment steps.
  • Who it is for: This tool is intended for clinicians, particularly those involved in cardiology and electrophysiology, who manage patients requiring cardiac monitoring and medication titration. It is being developed with the goal of expanding access to antiarrhythmic drugs for atrial fibrillation patients, especially in rural and minority populations, by enabling safe home-based monitoring during drug initiation.
  • How it fits a clinical or practice workflow: The SafeBeat Rx App is designed to be used from a mobile phone, allowing clinicians to remotely monitor patients and receive AI-based insights for treatment decisions. It aims to support outpatient drug loading and potentially reduce the need for three-day hospitalizations typically required for initiating certain oral cardiac medications. The platform integrates with various remote patient monitoring technologies, including remote therapeutic monitoring and cardiac implantable electronic device monitoring.
  • Notable capabilities: Key capabilities include specialized ECG analysis, AI-driven QTc measurement with high accuracy, and the ability to recommend antiarrhythmic drug dosing. The software is being developed to go beyond diagnostics to guide cardiac care and treatment management.

The SafeBeat Rx App is currently under development and is limited to investigational use only. A 510(k) application for approval of its QTc algorithm is underway with the FDA.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered treatment support
  • Cardiac arrhythmia monitoring
  • Pharmacological treatment guidance
  • Patient safety enhancement
  • Data-driven insights

Use Cases

  • Supporting medication management for arrhythmia patients
  • Monitoring patients on antiarrhythmic drugs
  • Assisting in treatment plan adjustments for cardiac arrhythmias
  • Enhancing patient safety during pharmacological treatment

Details

Category Cardiology AI, Pharmacology & Dosing AI
Pricing Unknown — unknown
DeploymentMobile App
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Cleared AI-estimated

The SafeBeat Rx App is listed on the FDA AI/ML-Enabled Medical Device List, indicating it has received FDA clearance as a medical device.

Integrations
EHR Not specified
Specialties Cardiology, Critical Care, Emergency Medicine

What the Web Says

SafeBeat Rx is an AI-powered ECG platform designed to move beyond diagnostics to recommend treatment for cardiac conditions, particularly atrial fibrillation. The app aims to enable safe at-home initiation of antiarrhythmic drugs, which traditionally require hospitalization. It leverages machine learning to automate QTc measurements from ECGs and provides treatment recommendations with high accuracy compared to physicians.

Overall: Positive

Strengths

  • Potential to dramatically improve care for patients requiring in-patient monitoring for drug initiation, improving patient care and workflows.
  • Ability to expand access to life-saving medications, especially for minority and rural populations who face barriers to hospitalization.
  • High QTc accuracy (5u00b17 ms) and 90% accuracy in recommending antiarrhythmic drug dosing compared to physicians.
  • Designed by clinicians for clinicians, with streamlined software for mobile use and explainable AI.
  • Addresses a critical gap in post-discharge cardiac surveillance and offers a novel approach to guideline-adherent pharmacological disease management.
  • Potential to reduce healthcare costs by enabling home-based care and reducing hospital readmissions.

Limitations

  • The product is currently under development and limited to investigational use only.
  • No readily available reviews from general users or a broad range of tech reviewers, G2, or Capterra, suggesting it's not yet widely adopted or publicly accessible for general review.
  • Limited information on potential challenges or drawbacks from a user experience perspective (e.g., app interface, ease of use for patients).
  • The Reddit search for 'heart rate monitor app' did not specifically mention SafeBeat Rx, indicating a lack of public discussion on that platform.
  • Competitors offer broader health monitoring capabilities or established market presence.

Based on reviews from: SafeBeat Rx u2013 Powering Cardiac Therapeutics u2013 All From Your Phone, SafeBeat Rx-Moving ECG AI Beyond Diagnostics to Recommending Treatment - PubMed, Novel, automated mobile heart rhythm analysis technology to start antiarrhythmic medications safely at home - NIH RePORTER, Safebeat Rx - Master of Translational Medicine - UC Berkeley & UCSF, From Software Release Bottlenecks to Automated Velocity: SafeBeat's Journey with Greenlight Guru, SafeBeat Rx-Moving ECG AI Beyond Diagnostics to Recommending Treatment | Request PDF - ResearchGate, SafeBeat Rx Funding | $5M-$10M Revenue | Complete Analysis - Extruct AI, Top 10 SafeBeat Alternatives & Competitors in 2026 - G2, SafeBeat: Guiding cardiac therapeutics - all from your phone - Y Combinator

Last updated: 2026-08-19

Ratings & Reviews

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Press & Coverage

FDA via Innolitics
SafeBeat Rx App (K251218) u2014 FDA 510(k)
The SafeBeat Rx App received FDA 510(k) clearance on February 6, 2026, for provisional ECG analysis, including interval measurements and waveform feature display, intended for use by qualified healthcare personnel in professional settings or for evaluating home-acquired ECGs.
2026-02
FDA
510(k) Premarket Notification - SafeBeat Rx App
This FDA 510(k) premarket notification details the clearance of the SafeBeat Rx App, listing SafeBeat Rx, Inc. as the applicant and providing regulatory information.
2026-02
IntuitionLabs
SF Bay Area Medtech: An Analysis of 1,000+ Companies - IntuitionLabs
The SafeBeat Rx App, an AI-powered ECG software for cardiac patient management, is highlighted as an example of AI-enabled diagnostics in the Bay Area medtech scene, having received FDA 510(k) clearance to analyze compatible single-lead ECG recordings.
2025-10
HealthAIdir
SafeBeat Rx App Review, Pricing & Alternatives - HealthAIdir
This article provides a review of the SafeBeat Rx App, including links to its official site and regulatory context from the FDA.
2026-06
FDA
TPLC - Total Product Life Cycle - accessdata.fda.gov
The SafeBeat Rx App is listed within the FDA's Total Product Life Cycle (TPLC) database as a programmable diagnostic computer.
2026-07
Kipra
510(k) - Kipra
The SafeBeat Rx App is listed with its 510(k) number (K251218) and decision date of February 6, 2026, in a database of FDA 510(k) clearances.
2026-02
NIH
gs1 - AccessGUDID - NIH
The SafeBeat Rx App is included in the AccessGUDID database, which provides unique device identification (UDI) information for medical devices.
unknown

Videos

Product demos, reviews, and walkthroughs for SafeBeat Rx App.

View all on YouTube

Frequently Asked Questions

The SafeBeat Rx App is designed to guide cardiac care by providing specialized ECG analysis and expanding access to remote therapeutic monitoring using third-party FDA-cleared cardiac monitoring devices. It aims to help clinicians quickly assess important patient information and customize treatment steps, potentially allowing atrial fibrillation patients to safely start antiarrhythmic medications at home, which traditionally requires hospitalization.
The SafeBeat Rx App utilizes unique algorithms and explainable AI to display diagnostic information and customized treatment steps for patients. It performs beat-by-beat ECG analysis, which has been validated against expert cardiologist adjudication, to help clinicians make informed, guideline-adherent pharmacological disease management decisions.
While the provided information doesn't explicitly detail patient compliance rates for the SafeBeat Rx App, the platform is designed with patient experience as a priority to unlock the full capabilities of digital health and remote care. The goal is to enable patients to start antiarrhythmic drugs safely at home, which implies a focus on user-friendly remote monitoring.
Alternative solutions for cardiac monitoring and clinical decision support include various medical apps for physicians such as MDCalc for medical calculations, DynaMed for evidence-based information, and Medscape for drug references. For cardiac monitoring specifically, alternatives include ambulatory Holter ECG systems, mobile cardiac telemetry (MCT), and wearable cardiac monitors with cellular connectivity offered by companies like Alternative Physician Solutions (APS).
Currently, the SafeBeat Rx App is under development and is not yet for sale. It is limited by federal law to investigational use only. While it has shown promising results in Phase-I equivalent studies with high QTc accuracy and AAD dosing recommendations, it is undergoing Phase II human studies to validate its algorithm on the intended patient population.
The pricing model for the SafeBeat Rx App is not publicly available as the product is currently under development and not for sale. Information regarding its cost for healthcare providers or clinics would likely be released closer to its commercial availability.

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Suggest an Edit → | Last Verified: 2026-08-19 | First Added: 2026-08-19
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