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    FDA clears VySpine’s VyPlate anterior cervical plate system

    VySpine this week announced it received FDA 510(k) clearance for its VyPlate anterior cervical plate system. Tallahassee, Florida-based VySpine designed VyPlate to stabilize the anterior cervical...

    Visibly receives FDA clearance for online visual acuity test

    The Visibly Digital Acuity Product uses a touchscreen mobile device paired with a computer to test how sharp a user's vision is at a...

    SyncThink’s EYE-SYNC receives CE mark

    SyncThink, a neurotechnology company, and makers of the EYE-SYNC technology, has completed CE Mark certification, affirming conformity to European Medical Device Regulation (MDR). EYE-SYNC...

    Bodyport’s noninvasive biomarker platform secures FDA 510(k) clearance

    The Bodyport Cardiac Scale allows individuals with fluid management conditions to monitor heart function and fluid status. Digital therapeutics firm Bodyport has received 510(k) clearance from the...

    The rise of SkyWalker: FDA clears surgical robot for orthopedic procedures

    Not so long ago in our very own galaxy, the FDA saw fit to expand its list of authorized robotic surgery systems—no epic interplanetary...

    Endologix Receives CE Mark Certification under EU-MDR for AFX®2 Endovascular AAA System

    Endologix Receives CE Mark Certification under EU-MDR for AFX®2 Endovascular AAA System Endologix LLC, a privately held global medical device company dedicated to improving patients’...

    Glaukos Announces FDA 510(k) Clearance of iStent infinite®

    MIGS Founder Leads with the First-Ever Micro-Invasive Implantable Device for Standalone Glaucoma Treatment Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused...

    Ambu Announces FDA Clearance of Fifth-Generation Single-Use Bronchoscope

    Ambu will extend market leadership in pulmonology by entering the bronchoscopy suite segment following U.S. and European market clearances. Ambu Inc. announces that Ambu® aScopeTM...

    AcuFocus Announces FDA Approval for the IC-8® Apthera™ Intraocular Lens, the First and Only Small Aperture Lens for Cataract Surgery

    The Apthera extended depth of focus IOL uses proprietary small aperture technology to filter out peripheral defocused light, allowing only focused light to reach...

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