FL-100 by Flow Neuroscience: status and timeline

Milestones

No announced next step

FDA premarket approval for major depressive disorder8 Dec 2025Complete.
US commercial launch1 Sep 2026Complete.

Most important updates

Flow Neuroscience launches FDA-approved FL-100 in the US market1 Sep 2026
FDA approves Flow Neuroscience FL-100 as first at-home brain stimulation device for depression8 Dec 2025

Current obstacles

Patient acceptance and adherenceHome-based treatment requires patient compliance over a 10-week course; determining optimal counseling and behavioral support strategies to maintain adherence.
Insurance reimbursementEstablishing coverage pathways with insurance companies to make treatment accessible to the broader depression patient population.

Physics limits

Spatial resolution and targetingCurrent application through the scalp stimulates broad brain regions rather than precise neural circuits, limiting the ability to target highly specific affected networks.
Individual neuroanatomical variabilityBrain anatomy and physiology differ between individuals, so optimal electrode placement and current settings may vary, potentially requiring personalization.

How it works

3 parts

Current application

Deliver current to prefrontal cortex

Forehead electrodes deliver 2 mA to the dorsolateral prefrontal cortex.

Mechanism

Shifts neural activity in mood circuits

Current changes neuronal firing likelihood, reducing depressive circuits.

Home protocol

Self-administered with app-based support

Wireless headset at home for 30-minute sessions with remote monitoring.

Spec sheet

Spec	FL-100
Stimulation current	2 milliampere^R (reported)
Session duration	30 minutes^R (reported)
Treatment course	10 weeks^R (reported)
Clinical remission rate (vs sham)	57.5% vs ~19%^R (reported)
Pivotal trial enrollment	174 patients^R (reported)

^R reported by the company

Update log

2 updates

Tue 1 Sep

Major: Flow Neuroscience launches FDA-approved FL-100 in the US marketPressCommercial

Mon 8 Dec 2025

Major: FDA approves Flow Neuroscience FL-100 as first at-home brain stimulation device for depressionPressRegulatory

About Flow Neuroscience

The team behind FL-100

Flow Neuroscience

tDCS depression treatment

Flow Neuroscience develops transcranial direct current stimulation (tDCS) devices for at-home treatment of depression. The company's FDA-approved FL-100 headset applies mild electrical current through the scalp to treat major depressive disorder.

FDA approval on 8 December 2025 for the FL-100 device as the first at-home tDCS system for depression treatment.
Pivotal trial showed 57.5% remission rate at 10 weeks versus sham control across 174 patients using 2 mA current for 30-minute sessions.
US commercial launch began September 2026 as a prescription-only treatment.

flowneuroscience.com (opens flowneuroscience.com)Company profile →

Founded: 201610 yrs
Headquarters: Sweden
Status: Private
Valuation: private
Works in: NeurotechStimulation therapies
Coverage: 1 program · 2 updateslatest 1 Sep 2026checked 10 Oct

Spec

FL-100

Stimulation current

2 milliampere^R (reported)

Session duration

30 minutes^R (reported)

Treatment course

10 weeks^R (reported)

Clinical remission rate (vs sham)

57.5% vs ~19%^R (reported)

Pivotal trial enrollment

174 patients^R (reported)