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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Opsens Inc > Regarding the 2 questions of the FDA

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Comment by ivebeenthereon Aug 29, 2022 11:49am

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Post# 34926890

RE:RE:RE:RE:RE:Regarding the 2 questions of the FDA

When one ask for FDA approval its certain there is going to be questions
to answer to in timely manner.I dont think that saying to someone that they answered
those two questions is privilege info because everybody knew beforehand that questions will
be asked .What would have been privilege information is if M. L would have told me
that they were not able to answer those questions.
Glta

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