Clinical trials for Sigknow Biomedical’s EZYPRO® after product release—The collection of clinical data

A small pilot study involving 25 participants was initiated for Sigknow Biomedical’s first product EZYPRO® ECG Recorder

EZYPRO® is certified by CE Marking for Medical Devices and TFDA.

Sigknow Biomedical’s first product EZYPRO® ECG Recorder has successfully acquired the certifications for medical products from both the European CE marking and Taiwan Food and Drug Administration in May and August 2017.

According to statistics by the US National Institutes of Health, the prevalence of arrhythmia is about 5% and it is expected to increase radically by 2.5 times due to population aging by 2050. While ECG recording can effectively detect arrhythmia, the current ECG recording devices may result in insufficient diagnosis or inconvenience to patients due to issues like short recording time and tangled wires.

EZYPRO® is a world-leading, first in Asia ECG patch that can record continuously for 14 days. The long-term continuous record can detect paroxysmal and asymptomatic arrhythmia. By assisting doctors to make diagnosis, it can provide timely treatment options, prevent serious complications like stroke and heart failure, and serve as an effective tool in regular post-cardiac surgery and catheter ablation follow-ups. It brings a good news to arrhythmia patients.