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    Evolution Optiks secures 510(k) clearance for new eye examination device

    Light field technology company Evolution Optiks has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its LFR-260, which is claimed...

    Intuitive earns updated FDA labeling on da Vinci X, Xi for radical prostatectomy

    Intuitive announced the FDA cleared a labelling revision for its da Vinci X and Xi surgical robotic platforms. It is based on real-world evidence...

    Moon Surgical wins FDA clearance for commercial version of Maestro surgical robot

    Moon Surgical received FDA clearance for the commercial version of its Maestro surgical robot system. The Paris-based company designed Maestro to provide an accessible,...

    Microbot’s LIBERTY robotic system secures FDA approval for pivotal trial

    Pre-clinical medical device company Microbot Medical has obtained US Food and Drug Administration (FDA) approval to proceed with its pivotal human clinical trial for...

    The FDA clears Zeto EEG brain monitoring technology

    Zeto announced received FDA 510(k) clearance for its One product for electroencephalography (EEG) brain monitoring. Santa Clara, California-based Zeto designed One to feature a...

    FDA clears InnoVoyce’s VYLO Laser System for medical use

    Medical technology company InnoVoyce’s VYLO Laser System has received 510(k) clearance from the US Food and Drug Administration (FDA). The VYLO Laser System, a 455nm...

    Canary Medical receives FDA breakthrough status for Lumbar Cartridge

    Canary Medical has received breakthrough device designation from the US Food and Drug Administration (FDA) for its smart spine device, Canturio Lumbar Cartridge (canturio...

    Spineart wins FDA clearance for anterior cervical cage

    The US Food and Drug Administration (FDA) has granted clearance to Spineart for its Scarlet AC-Ti anterior cervical cage. Cages are interbody devices used...

    Galvanize wins FDA nod for pulsed electric field endoscopic needle

    Galvanize announced the FDA granted 510(k) clearance for its Inumi Flex endoscopic needle with the Aliya system for soft tissue ablation. Inumi Flex expands the...

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