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    Immunexpress’ rapid sepsis test receives FDA clearance

    Immunexpress, a molecular diagnostic company focussed on improving outcomes for suspected sepsis patients, has received 510(k) clearance from the U.S. Food and Drug Administration...

    Cork-based Gasgon Medical wins Seedcorn Investor prize

    Cork-based medtech firm Gasgon Medical has been named the overall winner of the InterTradeIreland Seedcorn Investor Readiness Competition, pocketing a cash prize of €100,000. Press...

    Sound Life Sciences scores FDA 510(k) for smart device respiratory monitoring app

    The prescription app uses a smartphone or smart speaker to measure breathing. Sound Life Sciences scored FDA 510(k) clearance for its prescription app that uses...

    Wearable that detects sleep apnoea receives FDA clearance

    AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnoea (OSA) in adults, has obtained FDA 510(k)...

    Respira Labs seeks FDA clearance for its wearable lung monitor

    Respira Labs recently announced that it has developed a wearable device that continuously assesses lung function without the need for traditional pulmonary function tests. Mountain...

    PrecisionOS receives FDA 510(k) approval for VR surgical planning tool

    The InVisionOS officially received the clearance earlier this month and will be available in early 2022. PrecisionOS scored FDA 510(k) clearance for its InVisionOS tool that...

    Therapixel receives FDA clearance for use of its AI-based breast cancer screening software MammoScreen® on Digital Breast Tomosynthesis

    New 510(k) clearance expands the use of MammoScreen® from 2D to 3D mammography, opening up the entire breast cancer screening market Therapixel, a company leading...

    Smart sensor platform for respiratory health granted CE mark

    Strados Labs, a medical technology company using smart sensors to aid in early detection and predictions of worsening diseases for enhanced patient care, has been...

    iSTAR gains European approval for implant for glaucoma surgery

    iSTAR Medical, a medtech company developing novel minimally-invasive implants for glaucoma surgery (MIGS), has seen its MIGS device, MINIject approved in Europe for open-angle glaucoma patients.  Glaucoma...

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