Flow Neuroscience
Malmö, SwedenFounded 2016
- Neuromodulation
- Wearables
Flow Neuroscience provides an FDA-approved, prescription-based at-home transcranial direct current stimulation (tDCS) treatment for depression. Its platform is designed for use by patients at home under clinical guidance.
- FDA PMAFDA approval (PMA)
- 1
- Patents
- 10
- Founded
- 2016
- Employees
- 11–50
reccy insights
Flow Neuroscience reached a major commercialization milestone in 2025 and 2026. The company received FDA 510(k) clearance for at-home use of its brain-stimulation device for major depressive disorder, including monotherapy and adjunctive use. That regulatory development was reported on Jan 12, 2026, following coverage beginning in December 2025. On Sep 1, 2026, Flow launched FL-100 in the United States as a prescription-only, at-home tDCS treatment for eligible adults with moderate to severe major depressive disorder. The launch was covered on Sep 17, 2026 by BioSpace, while WIRED reported on Sep 15, 2026 that the headset had become available in the US. Coverage also indicated a price of approximately $2,200. The company acquired Halo Neuroscience on Feb 5, 2021, expanding its historical footprint in neurostimulation. Leadership has included CEO Erin Sivyer Lee, appointed on Apr 20, 2022, alongside co-founder and CTO Erik Rehn and co-founder and Chief Scientific Officer Daniel Månsson.
Written by reccy's AI from company sites, press and funding records · updated Oct 2026
What makes Flow Neuroscience distinct
- 01Describes itself as the first and only FDA-approved at-home tDCS treatment for depression.
- 02Makes prescription-based depression treatment available for use at home.
- 03Combines a brain-stimulation headset with a personalized mobile app.
- 04Addresses both stimulation-based and behavioral elements of depression treatment.
- 05Serves clinicians and patients through dedicated care pathways.
Technology & products5
- Flow tDCS Headset
A home-use medical device that delivers transcranial direct current stimulation to brain regions associated with mood regulation as part of depression treatment.
- Flow Treatment Program
An app-guided depression treatment program combining headset-based tDCS sessions, behavioral therapy exercises, symptom tracking, and treatment guidance for home use.
- Flow Replacement Pads
Replacement electrode pad sets used with the Flow tDCS Headset to conduct stimulation through the forehead during treatment sessions.
+ 2 more: Flow for Healthcare Providers, FL-100
FDA regulatory
- PMA· Class IIIClass IIIFlow FL-100
Cranial Electrotherapy Stimulator To Treat Depression · P230024 · product code JXK
1 supplement (design, labeling or process changes), latest Jul 14, 2026
Patents10
Recent updates4
- Sep 1, 2026Product launch
Flow Neuroscience launched FL-100 in the United States as a prescription-only, at-home tDCS treatment for eligible adults with moderate to severe major depressive disorder.
biospace.com - Dec 1, 2025Product launch
Flow Neuroscience was highlighted for offering an electroshock-based device intended to treat depression as a modern version of an established therapy.
inc.com - Dec 1, 2025Product launch
Flow Neuroscience received FDA 510(k) clearance for at-home use of its Flow brain-stimulation device for major depressive disorder, as monotherapy or adjunctive therapy.
bioworld.com
In the Cortex
- Flow Neuroscience Wins FDA Approval for At-Home Brain Stimulationneurofounders.co · Dec 11, 2025
- FDA Approves World’s First At-Home Brain Stimulation for Depressionflowneuroscience.com · Dec 11, 2025
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About Flow Neuroscience
- Products
- Flow tDCS Headset, Flow Treatment Program, Flow Replacement Pads, Flow for Healthcare Providers, FL-100
- Leadership
- Erik Rehn, CTO & Co-founderDaniel Månsson, Chief Scientific Officer and FounderErin Sivyer Lee, Chief Executive Officer
- Focus areas
- NeuroTechnology, medical devices, digital health, therapeutics, wearables, mental health, depression treatment, At-Home care
- Headquarters
- Malmö, Sweden
- Founded
- 2016
- Employees
- 11–50
- Patents granted
- 9 (Crunchbase)
- Trademarks
- 1