4 articles
Two weeks after securing Breakthrough Device Designation for stroke rehabilitation, CorTec has been accepted into the FDA's TAP — a dedicated advisory track that pairs the German neurotech company with an agency liaison and early engagement with CMS, signalling an unusually long regulatory horizon for an implanted brain-computer interface.
Michel Maharbiz departed iota Biosciences on 1 April and has emerged with a San Francisco BCI startup targeting post-stroke upper-limb rehabilitation, with a 64-channel epidural array, motorised glove, first-in-human at Lenox Hill later this year, and an FDA submission targeted for February 2027.
The German neurotech company becomes the first to receive FDA Breakthrough Device Designation for a brain-computer interface targeting motor recovery after stroke, with its closed-loop Brain Interchange system showing meaningful recovery in a Harborview Medical Center trial.
The startup, led by iota Biosciences founder Michel Maharbiz, is developing a minimally invasive brain-computer interface that pairs neural decoding with a motorized grip-assist glove to restore movement after stroke.
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