{"product_name":"HeartKey Rhythm","company_name":"B-Secur","product_url":"https://www.bsecur.com/heartkey-rhythm","company_url":"https://www.bsecur.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0180","summary":"HeartKey® Rhythm is an FDA-cleared ECG software suite by B-Secur, enhancing signal clarity and reducing noise for accurate cardiac monitoring in ambulatory settings.","description":"HeartKey® Rhythm is a suite of ECG algorithms and analytics developed by B-Secur to improve the accuracy and efficiency of cardiac monitoring. It enhances signal clarity by reducing noise, delivering high-quality ECG data. The software is FDA-cleared and can be implemented on devices or via the cloud through a Web API, integrating seamlessly with existing platforms and devices such as wearables and Holter monitors. Key features include advanced signal conditioning, rhythm detection, heart rate variability analysis, arrhythmia detection, stress analytics, and ECG-based user identification. These capabilities assist clinicians in making faster and more accurate diagnoses, thereby improving patient outcomes. HeartKey® Rhythm is validated against industry gold standards and is capable of consistent high performance on even the most challenging data. It is available for integration into a wide range of existing platforms and devices, offering flexibility and fast deployment. B-Secur, the company behind HeartKey® Rhythm, is ISO 13485:2016 certified, reflecting its commitment to quality and continuous improvement in medical device software development.","categories":["clinical Care","diagnostic Support","patient Facing","administrative Operations","Clinical","Diagnostic","Patient-facing","Administrative"],"market_segment":["enterprise","consumer"],"target_users":["clinicians","patients","admins"],"specialties":["Cardiology"],"regions_available":["United States","United Kingdom","Ireland","Europe","Asia","Australia","Canada","South America","Africa","Middle East"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Urdu","Turkish","Vietnamese","Thai","Polish"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United Kingdom","United States","Ireland"],"company_founding":"2015","deployment_model":["cloud","on_device","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Signal Processing Engine","Heart Rate Analytics","Heart Rate Variability (HRV) Analytics","Arrhythmia Analysis","Stress Analytics","ECG User ID"],"optional_modules":["Energy Expenditure"],"integrations":["Wearables","Holter monitors","Implantable devices","STM32 microcontrollers","TI AFE4950 analog front end"],"data_standards":["ECG","EKG"],"api_available":"yes","system_requirements":"STM32 microcontrollers, TI AFE4950 analog front end","compliance":["FDA 510(k)","ISO 13485:2016"],"certifications":["FDA 510(k)","ISO 13485:2016"],"security_features":["Signal encryption","User authentication via ECG","Data anonymization"],"privacy_features":["User consent management","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0180","slug":"heartkey-rhythm","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/heartkey-rhythm.json"}}