More
    Guided Solutions - Connecting Talent With Innovation/div>

    Penderia Technologies secures FDA Breakthrough Device Designation for Sensorized Soft Tissue Anchor System

    Penderia Technologies, a company developing wireless sensor technologies for orthopedic applications and in collaboration with MRC Global, LLC, recently received the FDA’s Breakthrough Device...

    ABANZA wins FDA clearance for WasherCap Mini fixation device

    ABANZA, a leader in advanced soft tissue repair solutions, shared the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its innovative...

    Averto Medical won FDA breakthrough device designation for ColoSeal

    Averto Medical, a clinical-stage medical device company pioneering minimally invasive gastrointestinal care, is pleased to announce that the U.S. Food and Drug Administration (FDA)...

    FDA clears Atreon’s bioresorbable synthetic implant for rotator cuff repair

    The US Food and Drug Administration (FDA) has granted 510(k) clearance to the BioCharge Autobiologic Matrix, a bioresorbable synthetic implant developed by startup Atreon...

    CathVision’s ECGenius system gains CE Mark, enabling European distribution

    CathVision has gained the CE Mark certification for its ECGenius system, enabling the company to market and distribute the system throughout the European Economic...

    QuantalX’s brain health assessment device gains CE MDR approval

    QuantalX Neuroscience has gained the European CE Medical Device Regulation (MDR) approval for the Delphi-MD, a device for assessing brain health. With this certification in...

    Neuvotion wins FDA 510(k) clearance for NeuStim neuromod wearable

    Neuvotion received FDA 510(k) clearance for its first product, the NeuStim wearable device. The company designed NeuStim to electrically stimulate muscles dynamically and with...

    Ibex Medical Analytics receives first FDA 510(k) clearance for Ibex Prostate Detect

    Ibex Medical Analytics, the leader in AI-powered cancer diagnostics, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Ibex Prostate...

    Gyder Surgical wins 510(k) FDA clearance for GYDER® Hip System

    Gyder Surgical, a MedTech company specialising in intuitive, orthopaedic navigation solutions, today announced the 510(k) FDA clearance for the GYDER® Hip System, the world’s...

    Latest articles