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    Regulatory Approvals

    Stryker’s bone tumour ablation system receives FDA 510(k) clearance

    The OptaBlate system allows physicians to easily customise their procedure and reduces ablation times by three minutes. Stryker has obtained 510(k) clearance from the US Food and Drug...

    BIOCORP announces the CE marking of SoloSmart®, an accessory medical device for SANOFI Solostar® pens at the occasion of EASD

    BIOCORP (FR0012788065 – ALCOR / Eligible PEA‐PME), a French company specialized in the design, development, and manufacturing of innovative medical devices, and SANOFI announced...

    FDA Approves Pascal TEER Device for Degenerative MR

    The CLASP IID randomized trial comparing the Pascal to the MitraClip will be presented Saturday at the TCT 2022 meeting. The US Food and Drug...

    Tasso receives FDA 510(k) for patch-like home blood collection device

    The company said the clearance will allow more pharma companies to use Tasso+ for decentralized clinical trials. Tasso received FDA 510(k) clearance for its patch-like blood...

    FDA Grants Breakthrough Device Designation for CurveBeam AI’s OssView™ Bone Fragility Software

    CurveBeam AI, Ltd announced its medical diagnostic software, OssView™, has received US Food and Drug Administration (FDA) Breakthrough Device Designation. OssView calculates a Structural...

    Magnus’ SAINT Neuromodulation System secures FDA 510(k) clearance

    The system combines advanced imaging technologies, personalised targeting and new stimulation patterns. Magnus Medical has secured US Food and Drug Administration (FDA) 510(k) clearance for its SAINT...

    Viz.ai receives FDA clearance for pulmonary embolism-related algorithm

    The new tool measures the diameter of the ventricles of the heart to provide the ratio of the maximum right ventricle diameter compared with...

    Noul obtains CE-IVD marks for two diagnostic testing products

    The miLab Cartridge CER stains and evaluates the cervical cells automatically to support the medical experts’ slide review. Biotech start-up Noul has received CE-IVD marks for its...

    eCential Robotics Announce FDA Clearance for its Surgical Robotic Platform for Spine Surgery

    eCential Robotics, have announced FDA 510(k) clearance of its 3D imaging, navigation and robotics guidance system, securing the penetration of its unified robotic platform...
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