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# Nanowear Wearable Diagnostic Cleared
- URL: https://www.fdaweb.com/nanowear-wearable-diagnostic-cleared/
- Published: 2024-01-05T12:00:00.000Z
- Updated: 2026-09-14T14:19:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156086

FDA has cleared a Nanowear 510(k) for the company’s SimpleSense, a nanotechnology-enabled wearable and software platform. “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,” the company says.

The company says the device is intended to capture and analyze more than 85 unique biomarker data points across the heart, lungs, hemodynamic, and central vascular system. “The platform provides high quality, continuous and time-synchronous biometric data, aggregating millisecond by millisecond cardiopulmonary assessments to assist medical professionals in remote patient management,” it says.