Design verification and validation of ViTrack - an accurate, continuous, non-invasive blood pressure monitor

PROJECT SUMMARY Current non-invasive blood pressure (BP) technologies are occlusive arm cuff-based and provide only single- point BP measurements. In US hospitals, 35 million critically ill patients annually require BP monitoring. Still, periodic cuff-based measures lead to monitoring gaps and complications, including 14 million episodes of acute kidney injury and myocardial injury annually. In hospitals, continuous BP monitoring can be achieved with invasive intra-arterial pressure (IAP) monitoring, but with significant risks. To address these limitations, Dynocardia has developed ViTrack, a continuous noninvasive BP (cNIBP). ViTrack is a cuff-less, wrist-wearable device with a proprietary optomechanical sensor and computer vision technology for accurate and continuous BP, heart, and advanced hemodynamic parameters. ViTrack is the first to measure beat-to-beat systolic (SBP) and diastolic (DBP) BPs directly without external calibration, irrespective of subject movement or wrist position relative to the heart (hydrostatic pressure change). In the SBIR Phase II study [1 R44 HL158374], we achieved the proposed milestones: (a) Improved the core ViTrack technologies and built minimal viable product (MVP); and (b) Clinical testing of MVP against IAP in 60 patients, demonstrated accurate and continuous waveform and BP readings every 20 seconds (Q20) regardless of movement, divergent BPs, abnormal heart rhythms, and hemodynamic conditions. Subsequently, we have achieved several milestones, including the successful deployment of the MVP in several renowned hospitals to demonstrate its effectiveness and gather user feedback. Based on the user feedback, we have completed the final product requirements and form factor and begun developing the production equivalent device in accordance with Design Controls. With the support of the CRP Program, we will complete the Verification and Validation (V&V) of the production-grade ViTrack hospital device. This will help to mitigate risks and enable us to submit the FDA 510k clearance. The ViTrack wearable will improve outcomes in critically ill hospital patients, leading to ~$14 B in annual savings in healthcare costs. The initial market validation in hospitals will facilitate expansion into other markets, such as remote patient monitoring, chronic disease management, and consumer wellness.