Motif Neurotech's DOT wins FDA IDE for first clinical trial in treatment-resistant depression

The FDA has approved Motif Neurotech's investigational device exemption to begin a first-in-patient clinical trial of DOT, a millimeter-scale epidurally implanted wirelessly powered brain stimulator that targets the prefrontal cortex. The Rice University spinout, backed by former Neuralink president Max Hodak among others, becomes one of the first companies to attempt an implantable depression therapy at the size and patient-acceptance profile that has eluded every prior DBS-for-depression programme.

Market Moves

China issues guided pricing for invasive BCI procedures as provinces begin reimbursement roll-out

China's National Healthcare Security Administration has set government-guided prices of 6,000–6,600 yuan per invasive brain-computer interface implantation procedure, with Sichuan, Hubei and Zhejiang now attaching fee schedules at the provincial level — moving the country further ahead of the United States on the reimbursement layer that will decide whether BCIs scale as routine medicine.

Apr 23 · 3 min read

Industry News

Maharbiz Launches Epia Neuro, a Stroke-Focused BCI Built for Lifelong Assistive Use

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.

Apr 22 · 4 min read