Share

Market insight in association with

ADHD device clears the path for treatments of neurological disorders

On 19 April, NeuroSigma was granted permission to market its Monarch external Trigeminal Nerve Stimulation (eTNS) System – the first medical device given this type of approval for the treatment of attention deficit hyperactivity disorder (ADHD) – by the US Food and Drug Administration (FDA).


ADHD non-drug treatment

ADHD is a common disorder, with symptoms beginning in childhood. Seven years is the average age of diagnosis. Children affected by ADHD often have difficulty controlling their behaviour, paying attention and staying focused. The US Census Bureau estimates that roughly 129 million children between the ages of five and 19 had ADHD in 2013. The current standard treatment is behavioural therapy and medication, with 6.1% of US children currently being treated for ADHD with medication. While the causes for ADHD are not precisely known, a combination of genetics, environment and improper neurological system development are thought to play a role.


Medical devices have been used as treatments for neurological disorders for a long time. In particular, neurostimulation (also known as neuromodulation) is one of the fastest-growing medical device markets.

The concept of modern neuromodulation began in the 1960s when deep-brain and spinal cord stimulators were developed and used to treat chronic, intractable pain. Since then, neurostimulation devices have been used to treat a wide array of diseases/disorders, including but not limited to Parkinson’s disease, epilepsy, major depression disorder, and even urinary and faecal incontinence. In general, neuro-stimulation devices work by delivering electrical signals directly to nerves.


GlobalData estimated the global market value for neurostimulation devices to be over $4.5bn in 2017 and projects exponential growth into the future. Medtronic commands this market, with Boston Scientific and Abbott Healthcare being other big players.


NeuroSigma is a Los Angeles-based life sciences company that focuses on manufacturing TNS devices for neurological disorders. Its Monarch eTNS system is a small, mobile phone-sized device with a small patch attached via a wire. The patch can adhere to the patient’s forehead while the patient is asleep and, under the supervision of a caregiver, delivers low-level electrical stimulation to branches of the trigeminal nerve, which then signals to the parts of the brain thought to be involved in ADHD. This device is intended for ADHD patients aged 7 to 12 who are not currently taking any prescription ADHD medication. A placebo-controlled clinical trial showed significant improvement in moderate to severe ADHD symptoms in patients who used the Monarch eTNS system compared to those who used the placebo device.


The Monarch eTNS System is the first neurostimulation device indicated for ADHD, and thus clears the path for future devices in treatments of other related neurological disorders. Factors that threaten this market are the lack of knowledge of the mechanisms that cause many neurological disorders and the high cost of these devices.


For more insight and data, visit the GlobalData Report Store.

Share this article

05/23/2024 01:13:07
  • Home | Risky Business: Reporting Medical Device Failures
  • Biointeractions Company Insight
  • Biointeractions
  • In This Issue
  • Formacoat Company Insight
  • Formacoat
  • Contents
  • MPS Microsystems Company Insight
  • MPS Microsystems
  • News
  • Sartorius
  • Mikron
  • The Medical Industry Briefing
  • Protomatic Medical Company Insight
  • Protomatic Medical
  • Regulating brain-device interface dilemmas
  • Telemed Company Insight
  • Telemed
  • Selling into the NHS: HEE’s top tips for medtech companies
  • Klingel Company Insight
  • Klingel
  • Cap Biomaterials
  • Israel: a medtech innovation hub for the world
  • Electronic Sensor Technology
  • Braxton Manufacturing
  • US medical device tax: should it be gone for good?
  • Micro Systems Technologies
  • Hidden figures: lifting the lid on medical device failure reporting
  • IMT Company Insight
  • IMT
  • Take a deep breath: this could be the future of cancer diagnosis
  • Smiths Interconnect
  • Current Health gains FDA clearance for in-home remote patient monitoring
  • Design Standards Corporation
  • 5G will revolutionise healthcare
  • Parmaco
  • Approval of ADHD neurostimulation device clears path for treatments of related neurological disorders
  • Mi3 Medical Intelligence
  • FDA warns against off-label use of Stryker’s Wingspan stent
  • Virtual reality heralds and exciting new era for treatment
  • Erdmann Design Switzerland
  • Events
  • Next Issue
06/06/2019 00:00:00