Nanowear Gets FDA’s 510(k) Clearance for AI-Based Diagnostics

New York City-based Nanowear has received an expanded 510(k) clearance from the FDA for the software that goes with its SimpleSense remote diagnostic platform.

Nanowear says the new clearance enables it to use artificial intelligence (AI) and deep learning algorithms for remote diagnoses based on more than 85 biomarkers tracked by the wearable device.  

The company is now seeking further clearances for diagnosing or monitoring hypertension, chronic obstructive pulmonary disease, sleep apnea, worsening heart failure and post-surgical recovery, among other conditions.