Nanowear’s Cloth-Based Monitoring System Earns 510(k) Clearance

The FDA has granted Nanowear 510(k) marketing clearance for SimpleSENSE, a cloth-based remote monitoring platform for the heart, lungs and upper vascular system.

The adjustable cloth strap of the device is worn on the torso where it “effectively replaces the digital stethoscope, multi-channel Holter monitor, Capnogram respiration machine and blood pressure cuff,” Nanowear said.

The company is conducting clinical trials to evaluate the device as a tool for diagnosing worsening heart failure and COVID-19.