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    Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand™ Upper Extremity Rehabilitation System

    IpsiHand exoskeleton uniquely leverages brain-computer interface technology for chronic stroke rehabilitation IpsiHand also has been granted U.S. FDA Breakthrough Device Designation Neurolutions, Inc., a medical device company...

    Edge Surgical wins patent for spinal surgery tech

    EDGe Surgical, Inc., a company focused on developing and manufacturing smart orthopedic and spine surgical instruments, announced today that its next-generation Awl-in-One Tap™ device...

    Cerus Endovascular Announces IDE Approval from the U.S. FDA to Conduct Clinical Study of the Contour Neurovascular System™

    Patient Enrollment to Begin Within Three Months Cerus Endovascular Ltd., a privately held, commercial-stage medical device company, today announced that the U.S. Food and Drug...

    Zimmer Biomet Secures FDA Clearance for ROSA® Partial Knee System

    ROSA® System is used for Robotically-Assisted Partial Knee Arthroplasty. Leader in musculoskeletal healthcare, Zimmer Biomet, has received FDA 510(k) clearance of the ROSA® Partial Knee System for...

    Empatica gets CE mark for EmbracePlus medical smartwatch

    A medical smartwatch for researchers and healthcare providers to collect continuous and objective data from patients, while enabling health monitoring at scale.  EmbracePlus by Empatica has...

    OncoSec Receives CE Mark Certification for its Commercial Electroporation Device “GenPulse™” for the Treatment of Solid Tumors

    CE mark enables commercialization of GenPulse™ in EU OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a biotechnology company focused on cytokine-based intratumoral immunotherapies, announced...

    AngioDynamics Submits 510(k) Application to FDA for AlphaVac Mechanical Thrombectomy System

    Thrombectomy Device with Off-Circuit Mechanical Aspiration Design for Treatment of Undesirable Intravascular Material in Venous System and Peripheral Vasculature. AngioDynamics, Inc. (NASDAQ: ANGO), a leading...

    Chemence Medical’s redesigned skin closure system approved by FDA

    The US Food and Drug Administration (FDA) has granted 510(k) approval to Chemence Medical’s redesigned Exofin fusion skin closure system. The US Food and Drug Administration (FDA)...

    Empirical Spine Receives FDA Breakthrough Device Designation for the LimiFlex Device Targeting Degenerative Spondylolisthesis

    The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis...

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