Fremont, California nanosensor technology firm Nanowear has launched a validation study as it looks to gain clearance for its diagnostic device for congestive heart failure management.

The company’s flagship product SimpleSense, a machine learning platform, is a non-invasive undergarment that measures a patient’s ECG, heart rate variability and respiratory rate, among other metrics.

The device’s algorithmic score “provides physicians and care management teams with alerts of worsening heart failure weeks in advance of a hospitalizing event,” the devicemaker said.