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    Regulatory Approvals

    Medtronic Receives CE Mark for Extravascular Defibrillator System That Treats Abnormal Heart Rhythms

    Medtronic plc (NYSE:MDT) has received CE (Conformité Européenne) Mark for the Aurora EV-ICD™ MRI SureScan™ (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV™ MRI SureScan™ defibrillation...

    Lumendi Receives 510(k) Clearance for Two New Devices

    Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable...

    Curiteva Inc. Announces FDA 510(k) Clearance for Inspire 3D Porous PEEK HAFUSE Cervical Interbody System

    Alabama-based technology company Curiteva announces the first FDA 510(k) cleared 3D-printed PEEK implant, the Inspire Porous PEEK Cervical Interbody System with HAFUSE Technology. The Inspire platform is...

    Sunrise secures FDA nod for its at-home sleep apnea test

    Belgium-based scale-up, Sunrise, announced the U.S. Food and Drug Administration (FDA) has cleared for use its second generation at-home sleep apnea test that uses artificial...

    FDA grants IDE approval for Concept Medical’s Coated Balloon

    The IDE approval will enable data on the safety and efficacy of the Magic Touch PTA Sirolimus Coated Balloon to be collected. The US Food...

    VideaHealth Perio Assist Receives FDA Clearance, Elevating Patient Care

    AI-powered image analysis tool expedites oral health analysis and measures radiographic signs of periodontal disease VideaHealth, the trusted dental artificial intelligence (AI) platform, announced the...

    Catalyst Receives FDA 510(k) Clearance for its Convertible Stemmed Total Shoulder Arthroplasty System

    Catalyst is first-to-market with a fully convertible system that features an ellipsoid anatomic head Catalyst OrthoScience Inc. (Catalyst), a medical device company focused on the upper...

    Stratasys has its first FDA-cleared medical device

    Stratasys (NASDAQ: SSYS) introduced its TrueDent resin for making 3D-printed dentures. TrueDent is the first FDA-cleared medical device for the company, which is based in Eden Prairie,...

    Boston Scientific Receives FDA Clearance for LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System

    Boston Scientific Corporation announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System, the first ureteroscope...
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