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Expanding the treatment toolkit: FDA-approved and cleared medical devices

In recent years, there has been a growing number of novel medical devices, both software and hardware, available to assist in the diagnosis and treatment of mental and behavioral health conditions including depression, generalized anxiety disorder, and insomnia. The U.S. Food and Drug Administration (FDA) regulates medical devicesopens in new window—a broad category of tools that encompasses both physical devices and software.

More precisely, a medical device (defined as in Section 201(h)(1) of the Food, Drug, and Cosmetic Act) is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory that is intended to diagnose, treat, prevent, cure or mitigate a disease or condition.

FDA also regulates Software as a Medical Deviceopens in new window, which is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

For those who may want to consider incorporating these devices into their clinical practice, below is a list of FDA-approved and cleared devices for the diagnosis or treatment of mental and behavioral health conditions, including descriptions of the device and links to the manufacturer website and FDA regulatory documentation for more information.

Software as a Medical Device (SaMD)

SaMDs are available on web platforms and/or in app formats. However, most are not publicly available to consumers through app stores. They require a prescription or “order” and are incorporated as part of a care plan with a treating clinician. Psychologists typically can “order” these tools if (1) the assessment and/or treatment of mental or behavioral health conditions is within their scope of practice and (2) the device manufacturer lists psychologists (or uses a term like qualified health care professional) as authorized users in the documentation submitted to the FDA. Questions, including whether and/or how a psychologist can access a specific tool, should be directed to the manufacturer and/or the FDA.

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Manufacturer: Cognoa Inc.opens in new window

Device classification name: Pediatric autism spectrum diagnosis aid

Description: Aids in the diagnosis of autism spectrum disorder (ASD) for children, ages 18 -72 months, who are at risk for developmental delay

FDA regulatory pathway: De Novo classificationopens in new window on 6/2/2021; 510k clearanceopens in new window on 4/11/2025

Code of federal regulations: 21 CFR 882.1491

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Big Health Inc.opens in new window

Device classification name: Computerized behavioral therapy device for anxiety disorders

Description: Treatment for generalized anxiety disorder (GAD) in adults, ages 22 and older

FDA regulatory pathway: 510k clearanceopens in new window on 8/30/2024

Code of federal regulations: 21 CFR 882.5801

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: EarliTec Diagnosticsopens in new window

Device classification name: Pediatric autism spectrum disorder diagnosis aid

Description: Aids in diagnosis and assessment of autism spectrum disorder for children, ages 16-30 months

FDA regulatory pathway: 510k clearanceopens in new window on 6/8/2022; 6/29/2023; 3/26/2025

Code of federal regulations: 21 CFR 882.1491

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Akili Interactive Labsopens in new window

Device classification name: Digital therapeutic software for attention deficit hyperactivity disorder

Description: Treatment to improve attention function for children, ages 8-17, with primarily inattentive or combined-type ADHD

FDA regulatory pathway: 510k clearanceopens in new window on 12/13/2023

Code of federal regulations: 21 CFR 882.5803

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Akili Interactive Labsopens in new window

Device classification name: Digital therapeutic software for attention deficit hyperactivity disorder

Description: Treatment to improve attention function for adults, ages 18 and older, with primarily inattentive or combined-type ADHD

FDA regulatory pathway: 510k clearanceopens in new window on 6/14/2024

Code of federal regulations: 21 CFR 882.5803

Current status: Available over the counter

Websiteopens in new window

Manufacturer: Original: Mahana Therapeutics Inc.

Device classification name: Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions

Description: Cognitive behavioral therapy for adults, ages 22 and older, who have been diagnosed with IBS

FDA regulatory pathway: 510k clearanceopens in new window on 6/2/2021

Code of federal regulations: 21 CFR 876.5960

Current status: 

Manufacturer: Curio Digital Therapeutics Inc.opens in new window

Device classification name: Computerized behavioral therapy device for depressive disorders

Description: Treatment for adult patients, ages 22 and older, with mild to moderate postpartum depression

FDA regulatory pathway: 510k clearanceopens in new window on 4/22/2024

Code of federal regulations: 21 CFR 882.5801

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Lumos Labs Inc.opens in new window

Device classification name: Digital therapeutic software for attention deficit hyperactivity disorder

Description: Treatment to improve attention function in adults, ages 22-55, with primarily inattentive or combined-type ADHD

FDA regulatory pathway: 510k clearanceopens in new window on 6/13/2025

Code of federal regulations: 21 CFR 882.5803

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Otsuka America Pharmaceutical Inc.opens in new window and Click Therapeuticsopens in new window

Device classification name: Computerized behavioral therapy device for depressive disorders

Description: Treatment for adult patients with MDD, ages 22 and older, who are on antidepressant medication

FDA regulatory pathway: 510kopens in new window clearance on 3/30/2024

Code of federal regulations: 21 CFR 882.5801

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer:
Original: Pear Therapeutics
Current: Pursue Careopens in new window

Device classification name: Computerized behavioral therapy device for substance use disorder

Description: Treatment for adult patients, ages 18 and older, with substance use disorder

FDA regulatory pathway: De Novoopens in new window classification on 5/16/2016

Code of federal regulations: 21 CFR 882.5801

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer:
Original: Pear Therapeutics
Current: Pursue Careopens in new window

Device classification name: Computerized behavioral therapy device for substance use disorder

Description: For adult patients, ages 18 and older, with opioid use disorder to increase retention in outpatient treatment

FDA regulatory pathway: 510kopens in new window clearance on 12/102018

Code of federal regulations: 21 CFR 882.5801

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: MetaMe Health Inc.opens in new window

Device classification name: Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions

Description: Treatment for adult patients, ages 22 and older, who have been diagnosed with IBS

FDA regulatory pathway: 510k clearanceopens in new window on 11/24/2021

Code of federal regulations: 21 CFR 876.5960

Current status:

  • Requires prescription or order
  • Has suspended distribution in the US
  • Available in Canada

Websiteopens in new window

Manufacturer: Big Health Inc.opens in new window

Device classification name: Computerized behavioral therapy device for insomnia

Description: Treatment for adult patients, ages 18 and older, with chronic insomnia

FDA regulatory pathway: 510k clearanceopens in new window on 8/5/2024

Code of federal regulations: 21 CFR 882.5801

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer:

Device classification name: Computerized behavioral therapy device for insomnia

Description: Treatment for adult patients, ages 22 and older, with chronic insomnia

FDA regulatory pathway: 510kopens in new window clearance on 3/23/2020

Code of federal regulations: 21 CFR 882.5801

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Swing Therapeutics Inc.opens in new window

Device classification name: Computerized behavioral therapy device for the treatment of fibromyalgia symptoms

Description: Treatment of fibromyalgia symptoms in adult patients

FDA regulatory pathway: De Novo classificationopens in new window on 5/9/2023

Code of federal regulations: 21 CFR 882.5804

Current status: Requires prescription or order

Websiteopens in new window

Transcranial magnetic stimulation

Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerves in the brain. It was first approved by the FDA for the treatment of major depressive disorder (MDD) in 2008. TMS is an outpatient treatment that often occurs in medical centers or specialized clinics. It is generally prescribed by and delivered under the supervision of a psychiatrist, but the type of health care provider that can prescribe and administer TMS may vary by state law. The number, frequency, and duration of treatments vary depending on the treatment protocol used and individual clinical needs.

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Manufacturer: Mag & More GmbHopens in new window

Device classification name: Transcranial magnetic stimulator 

Description: Treatment of MDD in adult patients who have not experienced satisfactory improvement from antidepressants; for adult patients with OCD; for adolescent patients (ages 15-21) with MDD 

FDA regulatory pathway: 510k clearance on 5/4/2018opens in new window; 5/24/2024; 8/18/2025; 9/4/2025

Code of federal regulations: 21 CFR 882.5805

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Remed Co. Ltd 

Device classification name: Transcranial magnetic stimulator

Description: Treatment of MDD in adult patients who have not experienced satisfactory improvement from antidepressants

FDA regulatory pathway: 510k clearance on 11/26/2021opens in new window; 4/6/2022 

Code of federal regulations: 21 CFR 882.5805

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: TeleEMG LLC

Device classification name: Transcranial magnetic stimulator

Description: Treatment of MDD in adult patients who have not experienced satisfactory improvement from antidepressants; for adult patients with OCD 

FDA regulatory pathway: 510k clearance on 12/22/2016opens in new window; 12/13/2017; 3/10/2023; 12/22/2023; 9/14/2025 

Code of federal regulations: 21 CFR 882.5805

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: BrainsWay Ltd.opens in new window 

Device classification name: Transcranial magnetic stimulator

Description: Treatment of depressive episodes and for decreasing anxiety (for those with comorbid anxiety symptoms) in adult patients with MDD who have not experienced satisfactory improvement from antidepressants; for adult patients with OCD; for adult patients to aid in smoking cessation; also indicated for the treatment of MDD in adolescents, ages 15-21 

FDA regulatory pathway: 510k clearance on 5/3/2018opens in new window, 3/8/2019, 8/21/2020, 4/16/2021, 4/23/2021, 8/17/2021, 8/26/2022, 5/31/2024, 9/13/2025, 11/7/2025 

Code of federal regulations: 21 CFR 882.5805 

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Magstimopens in new window

Device classification name: Transcranial magnetic stimulator

Description: Treatment of depressive episodes and for decreasing anxiety (for those with comorbid anxiety symptoms) in adult patients with MDD who have not experienced satisfactory improvement from antidepressant medication; for adults with OCD; indicated for treatment of MDD in adolescent patients ages 15-21 

FDA regulatory pathway: 510k clearance on 9/13/2017opens in new window, 8/3/2018, 3/15/2019, 4/3/2019, 9/14/2021, 1/13/2023, 3/16/2023, 10/25/2023, 8/30/2024, 3/17/2025

Code of federal regulations: 21 CFR 882.5805 

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Magnus Medical Incopens in new window 

Device classification name: Transcranial magnetic stimulator

Description: Treatment for MDD in adult patients who have not experienced satisfactory improvement from prior antidepressant medication 

FDA regulatory pathway: 510k clearance on 9/1/2022opens in new window 

Code of federal regulations: 21 CFR 882.5805

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Tonica Elektronik A/S 

Device classification name: Transcranial magnetic stimulator

Description: Treatment of depressive episodes and for decreasing anxiety symptoms (for those who may exhibit comorbid anxiety symptoms) in adult patients with MDD and who have not experienced satisfactory improvement from prior antidepressant medication; for adults with OCD; for adults (18+) with chronic post traumatic and post-surgical pain; for treatment of MDD in adolescent patients (ages 15-21) 

FDA regulatory pathway: 510k clearance on 10/5/2017opens in new window; 8/14/2018; 510k clearance on 8/9/2020, 3/17/2023, 8/25/2023, 7/30/2025; 8/8/2025, 8/11/2025 

Code of federal regulations: 21 CFR 882.5805

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Neuroneticsopens in new window 

Device classification name: Transcranial magnetic stimulator

Description: Treatment of depressive episodes and for decreasing anxiety symptoms (for those who may exhibit comorbid anxiety symptoms) in adult patients with MDD and who have not experienced satisfactory improvement from previous antidepressant 

FDA regulatory pathway: De novo classificationopens in new window on 10/7/2008; 510k clearance on 12/16/2008; 4/30/2013; 3/28/2014; 6/10/2016; 9/11/2016; 11/20/2020; 12/10/2021; 5/6/2022; 7/15/2022; 8/24/2022; 

Code of federal regulations: 21 CFR 882.5805

Current status: Requires prescription or order

Website

Manufacturer: Nexstim Plc

Device classification name: Transcranial magnetic stimulator

Description: Treatment for MDD in adult patients who have not experienced satisfactory improvement from prior antidepressant medication 

FDA regulatory pathway: 510k clearance on 11/10/2017opens in new window; 3/22/2019 

Code of federal regulations: 21 CFR 882.5805

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Brain Ultimate Inc.opens in new window 

Device classification name: Transcranial magnetic stimulator

Description: Treatment of MDD in adult patients who have not experienced satisfactory improvement from prior antidepressant medications; for adult patients with OCD 

FDA regulatory pathway: 510k clearance on 9/13/2023opens in new window; 4/17/2025; 

Code of federal regulations: 21 CFR 882.5805

Current status: Requires prescription or order

Websiteopens in new window

Virtual reality

Virtual reality (VR) devices use a headset to provide a 3-dimensional, computer-simulated immersive experience. VR is used in a variety of medical devicesopens in new window, including devices for the treatment of pain.

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Manufacturer: AppliedVRopens in new window 

Device classification name: Virtual reality behavioral therapy device for pain relief

Description: Treatment based on cognitive behavioral therapy skills and other evidence-based behavioral methods for patients, ages 18 and older, with a diagnosis of chronic lower back-pain 

FDA regulatory pathway: De novo classificationopens in new window 11/16/2021; 510k clearanceopens in new window on 12/4/2024; 8/13/2025 

Code of federal regulations: 21 CFR 890.5800

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Smileyscope Holding Inc. 

Device classification name: Virtual reality behavioral therapy device for pain relief

Description: Treatment to temporarily reduce and/or manage pain and temporarily relieve acute procedural anxiety associated with needle procedures for patients ages 4-11 years 

FDA regulatory pathway: 510k clearanceopens in new window on 9/25/2023 

Code of federal regulations: 21 CFR 890.5800

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: CognifiSense Inc.opens in new window 

Device classification name: Virtual reality behavioral therapy device for pain relief

Description: Treatment based on cognitive behavioral therapy skills and other evidence-based behavioral methods for patients, ages 18 and older, with a diagnosis of chronic lower back-pain 

FDA regulatory pathway: 510k clearanceopens in new window on 10/31/2023

Code of federal regulations: 21 CFR 890.5800 

Current status: Requires prescription or order

Websiteopens in new window

Biofeedback

Biofeedback devices use sensors to monitor and give real-time feedback about physiological functions, like breathing or heart rate, to increase the wearer’s awareness and ability to regulate those functions.

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Manufacturer: Brainmasteropens in new window

Device classification name: Device, biofeedback 

Description: Relaxation training using alpha EEG biofeedback 

FDA regulatory pathway: 510k clearanceopens in new window on 5/19/1999 

Code of federal regulations: 21 CFR 882.5050 

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Palo Alto Health Sciences Inc., later rebranded as Freespira 

Device classification name: Device, biofeedback 

Description: At home device for the treatment of symptoms associated with panic disorder and/or PTSD for patients ages 13 and older

FDA regulatory pathway: 510k clearanceopens in new window on 12/10/2013; 8/23/2018; 4/24/2025 

Code of federal regulations: 21 CFR 882.5050

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: GrayMatters Healthopens in new window

Device classification name: Device, biofeedback 

Description: Treatment for symptoms associated with PTSD

FDA regulatory pathway: 510k clearanceopens in new window on 3/17/2023

Code of federal regulations: 21 CFR 882.5050

Current status: Requires prescription or order

Wearables

Wearables are portable devices worn on the body, often employing both hardware and software components, to monitor symptoms and/or deliver an at-home treatment intervention. 

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Manufacturer: Cefaly Technology 

Device classification name: Stimulator, nerve, electrical, transcutaneous, for migraine

Description: At home wearable device for the treatment and prevention of migraine headaches in adults, ages 18 and older 

FDA regulatory pathway: De Novo classification on 3/11/2014opens in new window; 510k clearance on 3/4/2016; 9/15/2017; 11/28/2017; 9/29/2020; 12/13/2022; 7/18/2024 

Code of federal regulations: 21 CFR 882.5891

Current status: Available over the counteropens in new window 

Websiteopens in new window

Manufacturer: Flow Neuroscienceopens in new window 

Device classification name: Cranial electrotherapy stimulator to treat depression 

Description: At-home wearable headset for the treatment of moderate to severe MDD in patients, ages 18 and older, who are not considered treatment refractory to medication 

FDA regulatory pathway: Premarket approval on 12/8/2025opens in new window 

Code of federal regulations: 21 CFR 882.5800 

Current status: Requires prescription or order

Manufacturer: electroCore LLC

Device classification name: Non-invasive vagus nerve stimulator - headache 

Description: At home handheld device to prevent and treat migraines in patients, ages 12 and older; to prevent and treat cluster headaches in adults; to treat hemicrania continua and paroxysmal hemicrania in adults 

FDA regulatory pathway: De Novo classification on 4/14/2017opens in new window; 510k clearance on 5/30/2017; 12/7/2017; 1/23/2018; 3/30/2018; 11/27/2018; 3/26/2020; 2/12/2021; 9/10/2021 

Code of federal regulations: 21 CFR 882.5892

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Theranica Bio-Electronics LTD.

Device classification name: Distal transcutaneous electrical stimulator for treatment of acute migraine

Description: At home wearable device for the prevention and/or treatment of migraine in patients, ages 8 and older 

FDA regulatory pathway: De novo classification on 5/20/2019opens in new window; 510k clearance on 10/23/2020; 1/22/2021; 2/6/2023; 11/8/2023; 10/8/2024; 5/14/2025 

Code of federal regulations: 21 CFR 882.5899 

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Nightware Inc. 

Device classification name: Digital therapy device to reduce sleep disturbance for psychiatric conditions 

Description: Software paired with a smart watch for the reduction of sleep disturbance in adults, ages 22 and older, who have nightmare disorder or nightmares from PTSD 

FDA regulatory pathway: De Novo classificationopens in new window on 11/6/2020

Code of federal regulations: 21 CFR 882.5705

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: NeuroSigma Inc.opens in new window 

Device classification name: Transcutaneous nerve stimulator for ADHD 

Description: At home wearable device used during sleep for the treatment of children with ADHD, ages 7-12, who are not currently taking prescription ADHD medications 

FDA regulatory pathway: De novoopens in new window classification on 7/31/2018; 510k clearance on 1/16/2024 

Code of federal regulations: 21 CFR 882.5898 

Current status: Requires prescription or order

Websiteopens in new window

Manufacturer: Neurolief Ltd.opens in new window 

Device classification name: Cranial electrotherapy stimulator to treat depression 

Description: Wearable device for the treatment of MDD in adults who have not experienced satisfactory improvement from at least one previous antidepressant medication 

FDA regulatory pathway: Premarket approval on 12/31/2025opens in new window 

Code of federal regulations: 21 CFR 882.5800 

Current status: Requires prescription or order

Manufacturer: Neurolief Ltd. 

Device classification name: Stimulator, nerve, electrical, transcutaneous, for migraine 

Description: At home wearable device for the acute treatment of migraine with or without aura in patients, ages 18 and older 

FDA regulatory pathway: 510k clearance on 2/16/2021opens in new window; 8/2/2021 

Code of federal regulations: 21 CFR 882.5891

Current status: Requires prescription or order

Websiteopens in new window

Disclaimer

Identified products are provided for informational purposes only. All device details are based on information publicly available from the U.S. Food and Drug Administration (FDA) and have not been independently verified. The lists of devices in each category may not be exhaustive; these lists are updated at the discretion of APA so new products may come to market without being noted here. Users are encouraged to apply their own professional judgment and seek additional resources and guidance as needed. For questions about a specific device, please contact the manufacturer and/or reference FDA’s Medical Device Databasesopens in new window for more information regarding the device, its indications for use, and whether and/or how psychologists can order it. APA does not endorse any specific devices and assumes no responsibility for users’ obtaining particular devices or the outcomes of their use. Always comply with relevant ethical guidelines and legal requirements.

Date created: March 2026

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