Tag: fda breakthrough device
EShunt system receives US FDA Breakthrough Device designation for hydrocephalus treatment
Cerevasc has announced it has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its eShunt system, which is intended...
Onward Medical awarded US FDA Breakthrough Device designation for ARC-BCI system
Onward Medical announced recently that it has been awarded Breakthrough Device designation (BDD) by the US Food and Drug Administration (FDA) for the ARC-BCI system, which...
MindRhythm receives US FDA breakthrough designation for Harmony headset
MindRhythm has announced that the US Food and Drug Administration (FDA) has awarded a Breakthrough Device designation to its Harmony headset embedded with HeadPulse...
Reach Neuro receives Breakthrough Device designation for restorative stimulation device in...
Reach Neuro has been granted a Breakthrough Device designation by the US Food and Drug Administration (FDA) for its Avantis platform, which uses small...
Axoft launches ‘soft’ brain-implant technology, gains US FDA Breakthrough Device designation
Neurotechnology start-up Axoft has launched and announced US Food and Drug Administration (FDA) Breakthrough Device designation for its brain-machine interface (BMI) technology intended to...
Phagenesis announces US launch of neurostimulation system for post-stroke swallowing control
Phagenesis today announced that the US Food and Drug Administration (FDA) has granted a de novo request for the Phagenyx neurostimulation system, which uses...
Abbott receives Breakthrough Device designation to explore DBS in managing severe...
Abbott recently announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to investigate the use of its deep brain...
Carthera receives FDA Breakthrough Device designation for Sonocloud-9 system
Carthera announced today that its Sonocloud-9 system has been listed as a Breakthrough Device by the Center for Devices and Radiological Health (CDRH) at...
Rapid Medical receives FDA Breakthrough Device designation for vasospasm treatment
Rapid Medical has announced US Food and Drug Administration (FDA) Breakthrough Device designation for its Comaneci embolisation assist technology, which is intended to facilitate the treatment of...
Magnus Medical announces Breakthrough Device designation for novel depression treatment and...
Magnus Medical has announced that the US Food and Drug Administration (FDA) has granted the company Breakthrough Device designation for its individualised, rapid-acting, non-invasive...
MicroTransponder gains FDA approval for first-of-its-kind VNS system to improve stroke...
MicroTransponder has announced US Food and Drug Administration (FDA) premarket approval of the Vivistim paired vagus nerve stimulation (VNS) system, which—according to a company...
Neuros Medical gains FDA Breakthrough Device designation for Altius nerve block...
Neuros Medical has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for the use of its novel, high-frequency nerve block...
Sensome’s AI-powered stroke guidewire granted FDA Breakthrough Device designation
Sensome has announced its Clotild Smart Guidewire System—designed to improve the treatment of ischaemic stroke patients—has been granted a Breakthrough Device designation by the...
