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    The FDA clears Instylla’s Tembo Embolic System

    Instylla announced it has won FDA 510(k) clearance for its Tembo Embolic System. Bedford, Massachusetts-based Instylla said the Tembo system is a bioresorbable embolisation...

    NeuroBionics secures an oversubscribed $5m seed round to advance endovascular neuromodulation technology

    NeuroBionics, a neurotech company revolutionising neuromodulation therapy with minimally invasive implantable devices, today announced the successful close of its $5 million Seed Round. The...

    Stereotaxis wins European approval for robotic ablation catheter

    Stereotaxis has won European CE mark approval for its MaGiC ablation catheter, a robotically navigated device for the treatment of heart arrhythmia. Shares in the...

    FDA clears Nalu peripheral nerve stim tech for whole-body MRI

    Nalu Medical announced the FDA cleared expanded labelling of its peripheral nerve system to include whole-body MRI use. The clearance gives physicians greater flexibility...

    FDA grants second clearance to Gravitas Medical’s Entarik System

    Gravitas Medical has garnered a second U.S. Food and Drug Administration (FDA) 510(k) clearance for its Entarik technology for neonatal patients. “We are extremely pleased...

    FDA approves MediBeacon’s TGFR system for kidney function assessment

    The US Food and Drug Administration (FDA) has granted approval to the MediBeacon Transdermal GFR (TGFR) system for evaluating kidney function in individuals with...

    FDA grants IDE approval for NextBioMedical’s Nexsphere-F trial

    The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for NextBioMedical’s randomised trial involving its fast-resorbable embolic microsphere, Nexsphere-F,...

    SurGenTec receives FDA clearance for synthetic bone graft material

    SurGenTec has gained 510(k) clearance for OsteoFlo HydroFiber, a synthetic material for use in spinal surgery, from the US Food and Drug Administration (FDA). For...

    CergenX wins FDA breakthrough nod for neonatal brain monitoring tech

    CergenX announced the FDA granted breakthrough device designation for its Wave device for neonatal brain monitoring. Additionally, the FDA accepted the Cork, Ireland-based company...

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