BioTracker 2.0
Biotracker, LLCBioTracker 2.0 is a software tool that helps licensed healthcare professionals acquire, analyze, display, and report physiological data such as oxygen saturation, pulse rate, and blood pressure. It processes data from compatible medical devices to calculate cardiovascular parameters, assisting clinicians in assessing patient vascular health. The software is intended for use in primary care and outpatient settings and supports spot-check assessments rather than continuous monitoring.
Intended Use
BioTracker 2.0 is software intended to acquire, display, store, organize, and report physiological data obtained from compatible legally marketed physiological acquisition devices for review by licensed healthcare professionals.
Technology
BioTracker 2.0 connects to compatible biomedical devices including a pulse oximeter and blood pressure monitor, processes physiological signals using validated algorithms to compute parameters like HRV and ABI, and presents numerical values without making diagnostic interpretations. Data is stored locally in a HIPAA-compliant system with a graphical user interface guiding the clinician through workflows.
Performance
Non-clinical testing including ISO 14971:2019 risk management, software verification and validation per FDA guidance, and performance testing were conducted to demonstrate safety and effectiveness. Testing confirmed the software performs as per requirements without raising new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
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