Nexstim lands FDA clearance for non-invasive speech mapping
Finland-based Nexstim won FDA clearance for the NexSpeech upgrade, a speech-mapping module for its Navigated Brain Stimulation system for use in presurgical planning for patients with brain tumors.
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Mauna Kea wins Brazilian regulatory clearance for Cellvizio 100
Endomicroscopic devices maker Mauna Kea Technologies landed Brazilian regulatory approval for its Cellvizio 100, which it calls the world’s smallest microscope, for use inside the body during GI and pulmonology procedures.
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SomnoMed touts 510(k) win for SomnoDent
Texas-based SomnoMed landed FDA clearance for its SomnoDent obstructive sleep apnea treatment device.
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