Tag: fda breakthrough device

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...
vivistim system

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 quest study

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 clot out

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...