August 2017, California, USA
FDA clears Physiotrace Smart wearable and reusable device for exercise ECG monitoring
NimbleHeart’s Physiotracetm Smart got FDA’s class II 510(k) clearance to market. The Physiotracetm Smart has a wearable and reusable design that can be wrapped and fastened around the torso. The device uses dry ECG electrodes and embeds an ECG acquisition unit with a Bluetooth Low Energy transmitter. A mobile application controls the data acquisition, displays the status of the device, heart rate and optionally the ECG waveform during a recording session. The mobile App also stores the ECG and the exercise session information and relays it to a cloud server for permanent storage and review by healthcare staff. The Physiotracetm Smart is designed to be used without electrolytic gels and without adhesives that necessitate skin preparation.