FDA clears a NinePoint Medical 510(k) to market its Intelligent Real-time Image Segmentation software upgrade for its NvisionVLE Imaging System.
Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Policy Regarding Compliance Dates for Class I and Uncla...
Federal Register notice: FDA submits to OMB an information collection extension for Biosimilars User Fee Program.
A joint FDA panel meeting votes 17 to 1 that data support the benefit-risk profile of Sages Zulresso (brexanolone) injection for treating postpartum d...
FDA clears a Shoulder Innovations 510(k) for the InSet Humeral Short Stem System for partial or total shoulder arthroplasty used in the treatment of d...
FDA issues a safety alert about labels attached to some Pfizer/Mylan EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, which may block access to the a...
FDA Review posts the Federal Register notices for the week ending 11/2/2018.