• Neurotech Notables #45 (December 1–15, 2025) is a direct neurotechnology roundup from Neurotech Futures (Neurotechnology Substack).1
  • The roundup aligns with BCI and neurotech analyst focus.1 1

Weekly enrichment (2026-07-20)

  • Neurotech Notables #45 (covering December 1–15, 2025), written by Naveen Rao of Neurotech Futures for roughly 3,413 subscribers, was the newsletter’s final biweekly roundup of 2025.2
  • Neuralink hired former FDA official David McMullen to head medical affairs and reported reaching its 19th human-trial patient, including 7 in the United Kingdom.2
  • The issue led with Flow Neuroscience’s FDA approval of the FL-100, the first at-home transcranial direct-current-stimulation device for moderate-to-severe major depressive disorder in adults.2 3
  • Per the FDA premarket-approval record (P230024, approved December 8, 2025; breakthrough status since May 2022), FL-100 is indicated as monotherapy or adjunctive treatment for non-treatment-refractory MDD, with an at-home schedule of 5 sessions/week for 3 weeks then tapering; the pivotal “Empower” study reported 58% remission at 10 weeks.3 4
  • Funding highlights included Radial’s $50M round from General Catalyst for mental-health care and Saluda Medical raising $150M following an ASX IPO that Reuters called Australia’s weakest IPO debut in decades.2
  • Epiminder completed a $325M ASX listing plus a $125M capital raise, part of a wave of implantable-neurotech public-market and financing activity.2
  • The Astera Institute announced a new neuroscience program led by Doris Tsao, backed by more than $600M over the next decade, alongside an NSF “Tech Labs” initiative aiming to deploy roughly $1B into new research institutions.2
  • On the research and clinical front, the roundup flagged Medtronic’s expanded FDA nod for dystonia deep-brain stimulation, a Chinese BCI trial reporting brain-controlled grasping in all 32 paralysis patients, and a paper-thin brain chip packing 65,539 electrodes.2

Footnotes

  1. https://neurotechnology.substack.com/p/notables-45 2 3

  2. https://neurotechnology.substack.com/p/notables-45 2 3 4 5 6 7

  3. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-first-at-home-device-depression-2025-12-11/ 2

  4. https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230024B.pdf