Tag: IDE trial

vesalio

Vesalio announces completion of enrolment in acute ischaemic stroke IDE study

Vesalio has announced the completion of patient enrolment for the CLEAR US Food and Drug Administration (FDA) investigational device exemption (IDE) study utilising the NeVa...

FDA grants Aleva Neurotherapeutics approval for IDE study with directSTIM system

Aleva Neurotherapeutics has received a letter of approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) study assessing...

NeuroPace gains IDE approval to launch pivotal study of neuromodulation therapy...

NeuroPace has announced that it has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate the NAUTILUS...
rapid medical distals study

Rapid Medical to initiate trial expanding thrombectomy treatment across distal regions...

Rapid Medical today announced US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for what it claims is the first ever trial...
neuros quest study

Neuros Medical completes enrolment in QUEST pivotal study of novel post-amputation...

Neuros Medical—a medical device company developing novel high-frequency nerve block technology for patients with intractable post-amputation pain—has announced the completion of enrolment in its pivotal QUEST...
synchron stentrode safety

Synchron given green light to begin US study of endovascular brain-computer...

The Stentrode motor neuroprosthesis, developed by Synchron, has taken another step towards becoming the world’s first commercially available, endovascular brain-computer interface (BCI) technology after...
vesalio

Vesalio initiates new FDA stroke study following “milestone” VITAL trial enrolment

US medical device company Vesalio has announced the start of enrolment in the Vesalio CLEAR study—an acute ischaemic stroke FDA investigational device exemption (IDE)...

Mainstay Medical announces the completion of all implants in the ReActiv8-B...

Mainstay Medical International, a medical device company focused on bringing to market ReActiv8, an implantable neurostimulation system to treat chronic low back pain, announces...