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    Seer Medical receives FDA 510(k) for its at-home epilepsy diagnosis aide

    The company’s Seer Home device allows for potential epilepsy diagnosis through at-home data collection. Australian company Seer Medical received FDA 510(k) clearance for its at-home electroencephalograph (EEG)...

    Precisis lines up EU approval for ‘brain pacemaker’ to treat epilepsy

    Though drugs can help treat many cases of epilepsy, for the roughly 30% of patients with drug-resistant cases, it can take decades to find...

    FDA approves DyAnsys’ Primary Relief to treat pain after cardiac surgery

    The Primary Relief neurostimulation device administers periodic low-level electrical pulses to the ear for more than 72 hours. DyAnsys has received approval from the US Food and...

    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...

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