| Flow Neuroscience | |
|---|---|
| Type | Private |
| Industry | Medical devices, neurotechnology |
| Founded | January 2016, Malmö, Sweden |
| Headquarters | Malmö , Sweden |
| Products | Flow FL-100 (transcranial direct current stimulation device) |
| Website | www |
Flow Neuroscience is a Swedish medical technology company headquartered in Malmö that develops a wearable transcranial direct current stimulation (tDCS) device Flow (trade name Flow FL-100), for the treatment of major depressive disorder. The device delivers a low-intensity electrical current to the prefrontal cortex and is used together with a companion smartphone application.
In 2025, the U.S. Food and Drug Administration approved the Flow FL-100 through the premarket approval pathway for adults with moderate to severe major depressive disorder.
Flow Neuroscience was founded in Malmö in January 2016 by Daniel Månsson and Erik M. Rehn. In 2017, the company participated in the HAX hardware accelerator programme and received an Horizon 2020 SME Instrument grant.
In January 2018, it raised $1.1 million in seed funding led by Khosla Ventures. The company received European CE marking as a Class IIa medical device and launched the Flow headset in the United Kingdom and Sweden in June 2019.
In February 2021, Flow Neuroscience acquired the assets of San Francisco-based brain-stimulation company Halo Neuroscience, including its technology, research and development activities and patents. In August 2021, Flow Neuroscience raised approximately $9 million in a Series A round.
In April 2022, Erin Sivyer Lee became chief executive officer of Flow Neuroscience, with co-founder Daniel Månsson moving into a clinical and scientific role. The following month, the FDA granted the Flow FL-100 Breakthrough Device designation.
The company's pivotal randomized, sham-controlled trial of the device was published online in Nature Medicine in October 2024, with the print edition in January 2025.
The FDA issued its Premarket Approval letter for the Flow FL-100 (PMA P230024) on 8 December 2025; the decision was reported in the press between 11 and 15 December 2025.
In 2026, Flow Neuroscience received the Innovator of the Year award at the Malmö Business Awards, organised by the City of Malmö.
The Flow FL-100 is a wearable transcranial direct current stimulation (tDCS) device for home use in the treatment of major depressive disorder, used together with a companion application for treatment guidance and symptom tracking. The device delivers 2 mA of direct current for 30-minute sessions through electrodes placed over the dorsolateral prefrontal cortex, a region associated with mood regulation. Meta-analyses of tDCS trials for depression have found mixed results overall, with a modest but statistically significant effect compared to placebo.
Flow’s FL-100 was CE marked as a Class IIa medical device in the European Union in 2019 and transitioned to EU MDR in December 2026. The FL-100 is also UKCA marked in the United Kingdom. It was subsequently registered for sale in Switzerland, Norway, Hong Kong and the United Arab Emirates, and listed by the Therapeutic Goods Administration on the Australian Register of Therapeutic Goods in September 2025.
On 8 December 2025, the FDA approved the FL-100 through its Premarket Approval pathway (PMA P230024) as a Class III, prescription-only device for the treatment of moderate to severe major depressive disorder in adults, either as monotherapy or as an adjunct to medication. Commercial availability in the United States began on 1 September 2026.
Since 2023, several NHS trusts in England — including Northamptonshire Healthcare NHS Foundation Trust, Leicestershire Partnership NHS Trust, West London NHS Trust, Rotherham Doncaster and South Humber NHS Foundation Trust, Norfolk and Suffolk NHS Foundation Trust, South London and Maudsley NHS Foundation Trust, Lincolnshire Partnership NHS Foundation Trust, Devon NHS Partnership Trust, and Practitioner Health — have piloted or offered the Flow headset to eligible patients, generally as local service evaluations rather than as nationally commissioned treatment. A pilot with Leicestershire Partnership NHS Trust's crisis mental health team reported reduced depressive symptoms in around 80 percent of participants, and the programme was expanded in 2025.
In 2026, Flow Neuroscience's medical director, Dr Hannah Nearney, was named a fellow of the NHS Innovation Accelerator, a programme supporting the adoption of health innovations across the NHS.