Opsens Inc T.OPS

Healthcare Medical Devices

OpSens Inc. is a medical device cardiology-focused company. The Company offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. The Company’s segments include Medical and Industrial. The Medical segment focuses on physiological measurements, such as Fractional Flow Reserve (FFR) and Diastolic Pressure Ratio (dPR) in the coronary artery disease market and also supplies a range of miniature optical sensors to measure pressure and temperature to be used in a range of applications that can be integrated into other medical devices. The Industrial segment develops, manufactures and installs fiber optic sensing solutions for critical and demanding industrial applications. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and lesions access. It is approved for sale in the United States, European Union, Japan and Canada.

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Post by ivebeenthereon Mar 25, 2022 11:54am

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Post# 34545719

FDA

We are going to hear from Health Canada way before we hear anything from the FDA.
On november 23rd the CEO M. Laflamme said that they were going to file their appli-
cation to Health Canada in the first week of december 2021.
On the site of health Canada they say that 120 days is usually needed for a decision
to be taken.
M. Laflamme said also that the delay could be shorter because Health Canada had
allready lots of informations about the technology prior of the filing.

So do the math,120 days after the first week of december,it can be any day now.

Good luck to all