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Medical Devices

Vancouver Prostate Centre researchers develop blood test for cancer

Canada-based researchers at the Vancouver Prostate Centre and BC Cancer have developed a new blood test to study and treat cancer. The first-of-its-kind test provides...

SeaStar Medical seeks FDA HDE approval for Selective Cytopheretic Device

SeaStar Medical has submitted an application seeking a humanitarian device exemption (HDE) approval from the US Food and Drug Administration (FDA) to use its...

Companion Diagnostic: Overview of the Regulation

According to the definition provided by European Medicine Agency (EMA), a companion diagnostic is an in-vitro diagnostic test that supports the safe and effective use of a specific medicinal...

FDA Guidance on the PMA Supplement Decision-Making Process: Traditional PMA

The new article describes in detail the regulatory approach to be applied when determining the particular type of submission to be filed concerning the...

NeuroPace to Report Second Quarter 2022 Financial Results on August 11, 2022

MOUNTAIN VIEW, Calif., July 21, 2022 (GLOBE NEWSWIRE) -- NeuroPace, Inc., (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of...

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