BioBeat USA Inc.

BioBeat USA Inc. manufactures FDA-cleared cuffless, wireless, non-invasive 24-hour blood pressure monitoring systems. The company's primary product is a medical-grade chest patch that continuously measures ambulatory blood pressure (ABPM) without a traditional cuff, enabling uninterrupted sleep and eliminating white-coat syndrome artifacts. The system connects to a mobile application for real-time monitoring and automatically generates clinical reports within minutes of test completion. BioBeat's technology is validated against gold-standard cuff-based 24-hour monitoring and aligns with ACC/AHA Class 1a guidelines for hypertension diagnosis confirmation. The device addresses a clinical need for accurate, comfortable, guideline-concordant ABPM in office-based and hospital settings. BioBeat holds multiple FDA 510(k) clearances (K190792, K181006, K212153, K222010, K241066) and CE certification (CE 2797), demonstrating regulatory compliance in US and European markets. The company targets cardiology practices, primary care, and health systems seeking to improve hypertension diagnosis accuracy and patient compliance through comfort-driven monitoring.