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    Regulatory Approvals

    Device utilising sound to destroy tumors gets greenlight from FDA

    US-based histotripsy therapy firm has been given the green light by the US Food and Drug Administration (FDA) to bring its device that uses...

    TechMah CMF’s new tmCMF Solution receives US FDA clearance

    TechMah CMF has received US Food and Drug Administration 510(k) clearance for its new medical device, the tmCMF Solution. The new device includes personalised product solutions for...

    Allurion completes enrolment for its pivotal AUDACITY trial

    Allurion has completed patient enrolment in its pivotal trial designed to produce the necessary data for US Food and Drug Administration (FDA) approval of...

    Sleepiz wins FDA clearance for device that measures vitals during sleep

    The US Food and Drug Administration (FDA) has cleared Sleepiz’s bedside device that monitors patients’ vital signs during sleep. The Sleepiz One+ device uses radar...

    FDA grants Endotronix’s Cordella sensor IDE for second heart failure study

    The US Food and Drug Administration (FDA) has granted Endotronix’s Cordella sensor Investigational Device Exemption (IDE) for a second multicentre study, meaning the sensor...

    FDA rule change sees Laboratory Developed Tests regulated as medical devices

    Laboratory Developed Tests (LDT) are set to be regulated as medical devices under new rules proposed by the US Food and Drug Administration. The proposed...

    FDA approves Empaveli injector for PNH patients

    The device allows patients to administer their therapy subcutaneously from home or in the clinic to increase flexibility in their daily lives. The US Food...

    SeaStar gets FDA breakthrough status for Selective Cytopheretic Device

    SeaStar Medical has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for its patented cell-directed Selective Cytopheretic Device (SCD) to treat...

    FDA approves IDE for HYDRAFIL system in degenerative disc disease study

    The US Food and Drug Administration (FDA) has granted ReGelTec an investigational device exemption (IDE) for the company’s HYDRAFIL system. The device contains a polymer...
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