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    Regulatory Approvals

    FDA clears Tyber Medical’s Tibia Plating System

    Tyber Medical, a provider of private-label orthopaedic implants, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Proximal Tibia...

    Mainstay secures FDA approval for MRI labelling on ReActiv8 System

    Mainstay Medical has received the US Food and Drug Administration (FDA) approval for full-body MRI conditional labelling for its ReActiv8 Restorative Neurostimulation system. ReActiv8 is...

    ProCell secures CE-marked approval for blood recovery unit

    ProCell Surgical has received CE-marked approval for its Sponge Blood Recovery Unit, allowing it to enter the European Union market. The certification indicates that ProCell’s...

    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...
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