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    Regulatory Approvals

    FDA green lights StimLabs umbilical cord-derived wound graft

    The US Food and Drug Administration (FDA) has granted 510(k) clearance to US-based StimLabs wound care device Corplex P.  The device claims to be the...

    New UK NICE guidance endorses AI-derived software in stroke assessments

    A new guidance document from the UK National Institute of Health and Care Excellence (NICE) has endorsed National Health Service (NHS) deployment of two...

    Qure.ai adds new FDA breakthrough device status to growing list of regulatory milestones

    Medical imaging AI innovator, Qure.ai, has received breakthrough device designation from the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH)...

    Toku secures CE and UKCA mark approvals for CLAiR technology

    New Zealand-based medical device company Toku has secured the CE and UKCA marks for its patented CLAiR technology to evaluate cardiovascular disease (CVD) risk. The...

    FDA grants clearance for Hologic’s cervical cancer screening system

    The US Food and Drug Administration (FDA) has granted clearance for Hologic’s new Genius Digital Diagnostics System with the Genius Cervical AI algorithm for...

    Endogenex receives FDA approval for ReCET System trial

    Endogenex has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to commence a pivotal clinical study of the...

    NuvoAir’s Air Next Spirometer is FDA-approved for in-home use

    NuvoAir Medical announced its innovative Air Next Spirometer has received formal 510(k) clearance for in-home use as a full spirometer. 510(k) approval empowers NuvoAir...

    FDA approves Tyber Medical’s Mini-Frag System extension

    Tyber Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for an extension to its Mini-Frag System. The approval introduces additional...

    FDA Clears Magstim Transcranial Magnetic Stimulation System Horizon 3.0 with StimGuide Pro

    Magstim, the global leader in neuroscience research and treatment for mental health, has been awarded FDA clearance for the Horizon 3.0 with StimGuide Pro....
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