Nanowear Announces FDA 510(k) Clearance for AI-enabled Continuous Blood Pressure Monitoring and Hypertension Diagnostic Management: SimpleSense-BP
NEW YORK–(BUSINESS WIRE)–Nanowear, a leader in healthcare-at-home remote diagnostics, announced that its nanotechnology-enabled wearable and software platform, SimpleSenseTM, has received FDA 510(k) clearance for a novel AI-enabled Software-as-a-Medical Device (SaMD). As the first non-invasive, cuffless, continuous blood pressure monitor, and diagnostic, SimpleSense-BP provides a transformational tool in clinical diagnostic management of hypertension and is additive to the wearable platform’s previously cleared cardiopulmonary diagnostics.
