Nanowear wins FDA nod for AI-enabled wearable blood pressure monitor

The SimpleSense wearable platform. [Image courtesy of Nanowear]Nanowear announced today that its SimpleSense nanotechnology-enabled wearable and software platform received FDA 510(k) clearance.

The AI-enabled non-invasive, cuffless, continuous blood pressure monitor and diagnostic offers a tool in the diagnostic management of hypertension. It adds to the wearable platform’s previously cleared cardiopulmonary diagnostics. The FDA cleared it as software as a medical device (SaMD).

SimpleSense captures and analyzes more than 85 unique biomarker data points. It ranges across the heart, lungs, hemodynamic and central vascular system. The platform provides continuous, time-synchronous biometric data.

According to Nanowear, SimpleSense aggregates millisecond-by-millisecond cardiopulmonary assessments. This assists medical professionals in remote patient management. With proprietary nanosensors and algorithms, SimpleSense could offer an alternative to first-l…

Read more
  • 0