More
    Guided Solutions - Connecting Talent With Innovation/div>

    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...

    SPR Therapeutics Receives 510(k) Clearance of Technological Advancements and an Expanded Intended Patient Population for the SPRINT® PNS System

    SPR Therapeutics, a private medical device company focused on treating pain and improving the quality of life for patients managing acute or chronic pain,...

    Adaptix gets FDA 510(k) clearance for orthopaedic imaging system

    Avingtrans medical imaging technology associate firm Adaptix has received US Food and Drug Administration (FDA) 510(k) clearance for its orthopaedic medical imaging product. The Digital Tomosynthesis Orthopaedic imaging system, which...

    icotec gets FDA clearance for extended VADER Pedicle System

    The approval granted for the system includes Ø 4.5mm pedicle screws and extended long Carbon/PEEK rods. Swiss medical device manufacturer icotec ag has received 510(k)...

    Infinity Neuro Receives CE Mark Approval for Their First Device to Treat Stroke

    Infinity Neuro announced that its Inspira™ aspiration catheters received CE Mark approval and are now commercially available in Europe. This is the first offering from...

    Realize Medical wins FDA clearance for VR-based surgical planning software

    Realize Medical announced that it received FDA 510(k) clearance for its Elucis virtual reality (VR) software for surgical planning. The Ottawa, Canada-based startup designed Elucis...

    Proclaim XR Spinal Cord Stimulation Wins Approval for Painful Diabetic Peripheral Neuropathy

    The Abbott system previously earned approval for chronic pain in 2019, and adds another option for a patient population with no disease-modifying agents available...

    Varian Receives Investigational Device Exemption for RADIATE-VT™ Clinical Trial

    Varian, a Siemens Healthineers company, has announced that the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) for the pivotal...

    Latest articles