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

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Post by bossuon Aug 25, 2022 11:38am

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Post# 34919931

About FDA approval

To all posters

Just want to now if somebody know if OPS has sent its last answer to the FDA.
Accordindg to the company 60 days after the final filing the FDA has to come back with a decision.
I personnaly have not seen or heard about the last filing to the FDA

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