Flow Neuroscience
Flow Neuroscience is a Swedish medtech company that develops the FL-100, an FDA-approved at-home tDCS headset for treating major depressive disorder in adults, with 55,000+ users in Europe and the UK and a planned US launch in Q2 2026.
- Company typePrivate
- Founded2016
- HeadquartersMalmö, Sweden
- Headcount11–50
- GTM typeB2C
- OfferingHardware or Manufacturing
What Flow Neuroscience does
Flow Neuroscience is a Swedish medtech company headquartered in Malmö that develops a prescription at-home transcranial direct current stimulation (tDCS) headset for the treatment of major depressive disorder in adults. The company's core product, the FL-100, delivers mild electrical currents to the prefrontal cortex to modulate neural connectivity and is supported by a pivotal clinical trial published in Nature Medicine showing a 58% response rate and 45% remission rate after 10 weeks of treatment. The device received its first regulatory approval in England in 2019, was approved by the Australian TGA in October 2025, and obtained FDA approval in December 2025 as the first FDA-approved at-home non-drug neurostimulation therapy for depression in the United States, with commercial launch in the US planned for Q2 2026.
The company operates a dual-brand commercial model: the regulated Flow Neuroscience prescription channel for the FL-100 medical device, and the Halo Neuroscience brand (acquired in February 2021), which sells an identical tDCS hardware platform as an over-the-counter wellness device for approximately US $600. Distribution in Europe and the UK operates via direct-to-consumer and prescription channels, with over 55,000 users accumulated to date. The company is funded by Khosla Ventures, SOSV HAX, Global Brain Corporation, Kirin Holdings, and others, having raised approximately $12.5M cumulatively including a $9.96M Series A in August 2021. Leadership includes CEO Erin Sivyer Lee and co-founders Erik Rehn (CTO) and Daniel Månsson (CSO). The platform is positioned for expansion into additional neuropsychiatric indications including traumatic brain injury, addiction, and sleep disorders.
Flow Neuroscience firmographics
Firmographics- Name
- Flow Neuroscience
- Legal name
- Flow Neuroscience
- Website
- https://flowneuroscience.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Flow Neuroscience is a Swedish medtech company that develops the FL-100, an FDA-approved at-home tDCS headset for treating major depressive disorder in adults, with 55,000+ users in Europe and the UK and a planned US launch in Q2 2026.
- Ownership category
- akta.pro rank
Flow Neuroscience industry classification
Industry- Product category
- Neurostimulation Medical Devices
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- Electromedical & Electrotherapeutic Apparatus (3845)
- akta.pro primary industry
- Prescription Digital Therapeutics (PDT) (HLACANAB)
- akta.pro secondary industry
- Mental Wellness & Stress Management Devices (Biofeedback, Meditation/Neurostimulation Devices) (CRACAQAL)
Keywords
Where Flow Neuroscience is headquartered
LocationHeadquarters
- HQ city
- Malmö
- HQ country
- Sweden
- HQ region
- Europe
Offices1 record
Markets served
Flow Neuroscience business model
Business model- GTM type
- B2C
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Supply Chain, Operations
Revenue model
- Prescription Medical Device Sales (FL-100): Sale of the FDA-approved FL-100 tDCS headset as a prescription medical device for major depressive disorder. The device is available by prescription and launched in the U.S. in Q2 2026. Also available in Europe (approved in England since 2019) and Australia (TGA-approved October 2025).
- OTC Wellness Device Sales (Halo Neuroscience): Sale of the Halo Neuroscience-branded headset, an identical tDCS hardware platform marketed as a wellness device without a prescription for approximately US $600. This represents a consumer/over-the-counter revenue stream complementing the regulated medical device channel.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Flow Neuroscience FL-100 (Prescription Medical Device) — pricing not publicly disclosed |
| One time/ perpetual license | Pay-as-you-go | Halo Neuroscience OTC Wellness Headset — approximately US $600 |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels4 records
Flow Neuroscience product offering
Product offeringCore offering
Flow Neuroscience develops and sells the FL-100, a wearable transcranial direct current stimulation (tDCS) headset paired with a behavioral therapy app for at-home treatment of major depressive disorder in adults. The device delivers mild electrical currents to the prefrontal cortex and is the first FDA-approved at-home non-drug neurostimulation therapy for depression in the United States, distributed by prescription. An identical tDCS hardware platform is also sold over-the-counter as a wellness device under the Halo Neuroscience brand at approximately US $600.
Product overview
Flow Neuroscience offers a single unified product—the FL-100 at-home brain stimulation headset—which uses transcranial direct-current stimulation (tDCS) technology to treat major depressive disorder. The device delivers mild electrical currents to the brain's prefrontal cortex and represents the first FDA-approved at-home non-drug neurostimulation therapy for depression. The company previously received approval for the same technology in the UK (2019) and Australia (2025), with US commercial launch planned for Q2 2026.
Differentiator
Problem solved
Functional benefit
Brands
- Halo Neuroscience: Acquired brand that sells a headset using identical tDCS hardware as a wellness device without a prescription for around US $600.
Products and services
- Flow FL-100 Wearable transcranial direct current stimulation (tDCS) headset paired with a behavioral therapy app for at-home treatment of major depressive disorder in adults. Delivers mild electrical currents to the prefrontal cortex to improve neural connectivity; available by prescription.
- Halo Neuroscience Headset
Quantifiable outcome
- 58% response rate in pivotal trial vs 38% in sham/control group
- +4 more outcomes
Companies that use Flow Neuroscience
Customer profileNamed customers2 records
Segments3 records
Ideal customer profiles2 records
Flow Neuroscience technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Flow Neuroscience partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Halo NeurosciencecoreFlow Neuroscience acquired Halo Neuroscience in 2021. Under the Halo Neuroscience brand, the company sells a headset using identical tDCS hardware as a wellness device without a prescription for approximately US $600, complementing the regulated prescription Flow Neuroscience brand.
Scale indicators5 records
Recent moves6 records
Expansion highlights5 records
Flow Neuroscience competitors and assessment
Company assessmentDirect peers
- Neuronetics: Neuronetics markets NeuroStar, the leading transcranial magnetic stimulation (TMS) system for depression treatment. Both Flow and Neuronetics target major depressive disorder with non-drug neurostimulation, though Flow's tDCS is at-home and Neuronetics' TMS is clinic-based, making them direct competitors in the depression neurostimulation category.
- Brainsway: Brainsway develops deep transcranial magnetic stimulation (Deep TMS) systems for depression and other neuropsychiatric conditions. As a direct competitor in non-invasive brain stimulation for depression, Brainsway competes with Flow for the same patient population and prescriber base, though through a clinic-delivered model rather than at-home.
- Sooma: Sooma is a Finnish medical device company that develops tDCS devices for depression and other neurological conditions. Sooma is the closest direct competitor to Flow, using essentially the same tDCS technology targeting the same depression indication, with regulatory approvals in Europe.
- Ybrain: Ybrain is a Korean neurotechnology company developing wearable tDCS devices for depression and cognitive disorders. It is a direct tDCS competitor to Flow Neuroscience with overlapping technology approach and depression indication focus.
- Electromedical Products International (Alpha-Stim): Electromedical Products International manufactures Alpha-Stim, a cranial electrotherapy stimulation (CES) device for anxiety, insomnia, and depression. It is a direct competitor in the consumer/clinical non-invasive brain stimulation category, with FDA clearance and overlapping customer base seeking drug-free mental health treatment.
Emerging players
- Apollo Neuroscience: Apollo Neuroscience sells a wearable consumer neurostimulation device marketed for stress, sleep, and focus. While not FDA-approved for depression treatment, it overlaps with Flow's Halo Neuroscience OTC brand in the consumer brain stimulation wellness category.
- Big Health: Big Health develops FDA-cleared digital therapeutics (Sleepio for insomnia, Daylight for anxiety) that compete for the same medication-averse mental health patients. While Big Health uses CBT-based software rather than hardware, it is an emerging competitor in the digital therapeutics-for-depression space where Flow also operates.
- Limbic: Limbic is a digital mental health company offering AI-powered therapy support and self-referral tools. While not a neurostimulation competitor, Limbic addresses overlapping mental health patient needs through a digital/software approach, representing a different modality competing for the same patient demand for non-pharmaceutical depression treatment.
Broad incumbents
- Pear Therapeutics (defunct/asset sales): Pear Therapeutics was a pioneer in prescription digital therapeutics (PDT) with FDA-authorized products for substance use disorder and insomnia. While the company filed for bankruptcy in 2023, it set precedents on FDA PDT pathways and reimbursement that are relevant to Flow's prescription digital therapeutics strategy.
- Magstim: Magstim is a well-established manufacturer of transcranial magnetic stimulation (TMS) systems used in clinical research and depression treatment. As an incumbent neurostimulation equipment maker with broader neuroscience applications, Magstim is a broad incumbent competitor whose TMS technology targets the same depression treatment market as Flow's tDCS.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Flow Neuroscience social profiles
Digital presenceFlow Neuroscience financial estimates
Financial estimateRevenue estimate
Valuation estimate
Flow Neuroscience leadership team
Management profileNumber of profiles
Profiles3 records
Flow Neuroscience subsidiaries and ownership
Company hierarchySubsidiaries1 record
Flow Neuroscience funding detail
Funding detailFunding overview
Funding rounds7 records
Investors12 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Flow Neuroscience M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Flow Neuroscience
What does Flow Neuroscience do?
Flow Neuroscience develops and sells the FL-100, a wearable transcranial direct current stimulation (tDCS) headset paired with a behavioral therapy app for at-home treatment of major depressive disorder in adults. The device delivers mild electrical currents to the prefrontal cortex and is the first FDA-approved at-home non-drug neurostimulation therapy for depression in the United States, distributed by prescription. An identical tDCS hardware platform is also sold over-the-counter as a wellness device under the Halo Neuroscience brand at approximately US $600.
Is Flow Neuroscience a public or private company?
Flow Neuroscience is a private company. It is classified as venture growth investor backed and is currently operating.
When was Flow Neuroscience founded?
Flow Neuroscience was founded in 2016. It employs 11 to 50 people.
Where is Flow Neuroscience based?
Flow Neuroscience is headquartered in Malmö, Sweden, in the Europe region.
How does Flow Neuroscience make money?
Two revenue lines are on record. Prescription Medical Device Sales (FL-100) is the primary driver. The others are OTC Wellness Device Sales (Halo Neuroscience).
Who are Flow Neuroscience's main competitors?
Direct peers on record are Neuronetics, Brainsway, Sooma, Ybrain and Electromedical Products International (Alpha-Stim). Emerging players are Apollo Neuroscience, Big Health and Limbic. Broad incumbents are Pear Therapeutics (defunct/asset sales) and Magstim.
Does Flow Neuroscience have an API?
No public API is recorded for Flow Neuroscience.
What industry is Flow Neuroscience in?
Flow Neuroscience's product category is Neurostimulation Medical Devices. Its primary akta.pro industry code is HLACANAB, Prescription Digital Therapeutics (PDT), with a secondary code of CRACAQAL, Mental Wellness & Stress Management Devices (Biofeedback, Meditation/Neurostimulation Devices). Its NAICS code is 334510 and its SIC code is 3845.