Nanowear, a leader in remote healthcare diagnostics, has recently received FDA 510(k) clearance for its innovative AI-enabled Software-as-a-Medical Device (SaMD) featured in the SimpleSenseTM wearable and software platform. Serving as the inaugural non-invasive, cuffless, continuous blood pressure monitor and diagnostic tool, SimpleSense-BP represents a significant advancement in managing hypertension clinically. This clearance adds to the existing FDA approvals for cardiopulmonary diagnostics on the wearable platform.
This development is a noteworthy milestone for Nanowear, particularly in response to the growing demand for reliable, clinical-grade wearable solutions during the pandemic. SimpleSense-BP aligns with market expectations, offering at-home usability, AI integration, and a proven execution team. This SaMD showcases Nanowear's capabilities in nanotechnology and AI, providing personalized risk signatures and cardiopulmonary care pathways for precision medicine.
SimpleSenseTM, the FDA-cleared AI-enabled digital platform and wearable device, analyzes over 85 unique biomarker data points related to the heart, lungs, hemodynamics, and central vascular system. It offers continuous, high-quality, and time-synchronous biometric data for remote patient management. With proprietary nanosensors and algorithms, SimpleSenseTM stands as the world's first all-in-one wearable platform, replacing traditional diagnostic tools such as the blood pressure line, digital stethoscope, multi-channel ECG, hemodynamic monitor, pulse oximeter, spirometer, and actigraphy monitors.