Flow Neuroscience

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.

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

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

• Brain stimulation devices
• Depression treatment
• Neurostimulation therapy
• Mental health devices
• TDCS technology

Headquarters

HQ city

Malmö

HQ country

Sweden

HQ region

Europe

Offices1 record

Markets served

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Marketing or Sales, Supply Chain, Operations

Revenue model

1. 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).
2. 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

Go-to-market motion1 record

Distribution channels4 records

Marketing channels4 records

Core 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

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Halo NeurosciencecoreOEM/ Whitelabel/ Licensing Partner · 1 January 2021Flow 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

Direct 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

• Xx.com/flowneurosci
• Facebookfacebook.com/flowneuroscience

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds7 records

Investors12 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Flow Neuroscience