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# Nanowear’s SimpleSense Undergarment Monitor Cleared
- URL: https://www.fdaweb.com/nanowears-simplesense-undergarment-monitor-cleared/
- Published: 2020-11-11T12:00:00.000Z
- Updated: 2026-09-14T16:35:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148070

FDA has cleared a Nanowear 510(k) for its cloth-based diagnostic platform SimpleSense, a multi-parameter remote diagnostic undergarment and machine learning digital platform that monitors and assesses the heart, lungs, and upper vascular system. “Gender-neutral and size adjustable, the SimpleSense platform effectively replaces the digital stethoscope, multi-channel Holter monitor, Capnogram respiration machine, and blood pressure cuff by providing a diagnostic quality monitoring system that remotely captures more than 100 million data points per patient per day across cardiac, pulmonary, and circulatory biomarkers,” the company says.