This section highlights FDA-related milestones and regulatory updates for drugs developed by Brainsway (BWAY).
Over the past two years, Brainsway has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Deep and Deep. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Deep TMS FDA Regulatory Timeline and Events
Deep TMS is a drug developed by Brainsway for the following indication: Decreasing Anxiety Symptoms in Depressed Patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Deep TMS
- Announced Date:
- January 21, 2026
- Indication:
- Decreasing Anxiety Symptoms in Depressed Patients
Announcement
BrainsWay Ltd. announced that Highmark Blue Cross Blue Shield®, a company with over seven million covered lives that primarily serves Pennsylvania, Delaware, West Virginia, and parts of New York, has released a draft medical policy which, among other developments, expands coverage to include adolescent and adult patients with major depressive disorder (MDD) treated with the company's accelerated Deep TMS™ protocol.
AI Summary
BrainsWay announced that Highmark Blue Cross Blue Shield, a payer with more than seven million covered lives serving Pennsylvania, Delaware, West Virginia and parts of New York, has issued a draft medical policy that would expand coverage to adolescent and adult patients with major depressive disorder (MDD) treated with BrainsWay’s accelerated Deep TMS™ protocol. The draft is open for comment and is expected to take effect in February 2026 if adopted.
The policy would cover BrainsWay’s accelerated SWIFT™ (Short-course with Intrinsic Field Targeting) protocol: an acute phase of five ten‑minute treatment sessions per day for six days, followed by two sessions per day once a week for four weeks, totaling 38 sessions. Accelerated Deep TMS does not require functional MRI or other costly neuronavigation equipment. BrainsWay says broader payer coverage could give patients more flexibility and reduce the number of clinic visits needed for depression treatment.
Read Announcement- Drug:
- Deep TMS
- Announced Date:
- November 13, 2025
- Indication:
- Decreasing Anxiety Symptoms in Depressed Patients
Announcement
BrainsWay Ltd.announced that the U.S. Food and Drug Administration (FDA) has granted a label expansion for the Deep Transcranial Magnetic Stimulation (Deep TMS™) system making the treatment available as an adjunct therapy for adolescents aged 15 to 21 years suffering from major depressive disorder (MDD).
AI Summary
BrainsWay announced that the U.S. Food and Drug Administration has granted a label expansion for its Deep Transcranial Magnetic Stimulation (Deep TMS™) system, allowing its use as an adjunct therapy for adolescents aged 15 to 21 with major depressive disorder (MDD). Deep TMS is a noninvasive neuromodulation treatment intended to reduce depressive symptoms when used alongside other therapies.
The 510(k) clearance was supported by real-world data from 1,120 adolescents treated at 35 U.S. TMS centers between 2012 and 2024, using high-frequency (18 Hz) and intermittent theta-burst (iTBS) protocols. After 36 sessions, patients showed an average 12.1-point improvement on the PHQ-9 and a 66.1% response rate (≥50% improvement). Meaningful reductions in anxiety were seen on the GAD-7, and safety outcomes were consistent with prior TMS studies.
This expansion could increase treatment options for adolescents with MDD, a group often underserved by traditional medications, and may help clinicians offer an evidence-based, noninvasive therapy for young patients.
Read Announcement- Drug:
- Deep TMS
- Announced Date:
- September 16, 2025
- Indication:
- Decreasing Anxiety Symptoms in Depressed Patients
Announcement
BrainsWay Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted an expansion of the cleared treatment protocols for the Company's Deep Transcranial Magnetic Stimulation system (Deep TMS™) to include an accelerated protocol for the treatment of patients with major depressive disorder (MDD) including those with comorbid anxiety symptoms.
AI Summary
BrainsWay Ltd. announced that the U.S. Food and Drug Administration has expanded the cleared treatment protocols for its Deep Transcranial Magnetic Stimulation system (Deep TMS™) to include an accelerated protocol for patients with major depressive disorder, including those with comorbid anxiety. This new protocol is now commercially available in the United States.
In a multisite, randomized, blinded, controlled trial, the accelerated protocol showed comparable results to the standard Deep TMS treatment. Both groups saw reductions of about 19 points in depression scores (HDRS-21). Response and remission rates in the accelerated group were 87.8% and 78.0%, respectively, versus 87.5% and 87.5% in the standard group. Median time to remission was 21 days for the accelerated group and 28 days for the standard group.
The accelerated protocol consists of five 10-minute sessions per day for six days (over two weeks), followed by two sessions per day once a week for four weeks. The standard protocol involves five 20-minute sessions per day for four weeks, then two sessions per week for two weeks.
BrainsWay plans to train healthcare providers on the new accelerated protocol and is pursuing updated reimbursement to support wider patient access.
Read Announcement- Drug:
- Deep TMS
- Announced Date:
- June 11, 2025
- Indication:
- Decreasing Anxiety Symptoms in Depressed Patients
Announcement
BrainsWay Ltd. announced preliminary results from a multicenter, randomized controlled trial titled, "Accelerated Deep TMS for Depression: Results from a Multisite, Randomized Non-Inferiority Trial."
AI Summary
BrainsWay Ltd. recently shared preliminary results from a large, multicenter, randomized controlled trial comparing accelerated Deep TMS treatment to the standard once-daily protocol for depression. In the study, 104 adults with major depressive disorder were divided into two groups. One group received the standard Deep TMS treatment while the other followed an accelerated protocol that involved five short sessions per day over six days, followed by eight sessions over four weeks. The findings showed that both groups experienced similar improvements in depressive symptoms, with significant reductions in HDRS scores. Furthermore, the accelerated treatment led to a faster median time to remission—21 days compared to 28 days—with similar response and remission rates. Importantly, the accelerated method was well tolerated with only mild side effects, pointing to a promising option for patients who struggle with frequent clinic visits.
Read Announcement- Drug:
- Deep TMS
- Announced Date:
- October 9, 2024
- Indication:
- Decreasing Anxiety Symptoms in Depressed Patients
Announcement
BrainsWay Ltd announced the further expansion of its Deep Transcranial Magnetic Stimulation (Deep TMS™) platform in East Asia through the placement of 15 new systems in Taiwan and South Korea.
AI Summary
BrainsWay Ltd. announced the expansion of its Deep Transcranial Magnetic Stimulation (Deep TMS™) platform in East Asia by placing 15 new systems in Taiwan and South Korea. This move underscores the rising demand for the company’s innovative neurostimulation technology in this important region. Hadar Levy, the CEO of BrainsWay, stated that these installations in mental health centers are a key part of the firm’s strategy to extend its global presence and improve access to effective treatments for mental health disorders.
The Deep TMS platform has been used to treat various psychiatric conditions by offering noninvasive stimulation methods. By working with local partners and healthcare providers, BrainsWay continues to focus on expanding the availability of this technology, which is designed to enhance patient care and transform lives around the world.
Read Announcement- Drug:
- Deep TMS
- Announced Date:
- June 10, 2024
- Indication:
- Decreasing Anxiety Symptoms in Depressed Patients
Announcement
BrainsWay Ltd. announced the initiation of a prospective, randomized, controlled, multicenter clinical trial evaluating an accelerated treatment protocol for the Company's proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) system to treat major depressive disorder (MDD).
AI Summary
BrainsWay Ltd. has launched a new clinical trial to test an accelerated treatment protocol using its Deep Transcranial Magnetic Stimulation (Deep TMS™) system for major depressive disorder (MDD). This multicenter, prospective, randomized, controlled study will enroll over 100 patients at various clinical sites across the U.S. Participants will be divided into two groups: one receiving an accelerated treatment with multiple "theta burst" sessions in a few days, and the other receiving the standard FDA-cleared protocol, which delivers one session per day over several weeks.
The trial has been designed in discussion with the U.S. Food and Drug Administration to assess if the accelerated protocol is as effective as the traditional protocol. The study aims to provide conclusive evidence on whether a shorter treatment period can offer similar benefits, potentially making Deep TMS more convenient and appealing for patients suffering from MDD.
Read Announcement- Drug:
- Deep TMS
- Announced Date:
- June 3, 2024
- Indication:
- Decreasing Anxiety Symptoms in Depressed Patients
Announcement
BrainsWay Ltd. announced that the US Food and Drug Administration (FDA) has granted an expanded indication for the Company's Deep Transcranial Magnetic Stimulation system (Deep TMS™) allowing for the treatment of patients with major depressive disorder (MDD) ages 22 to 86, changing the previous upper age limit of 68.
AI Summary
BrainsWay Ltd. announced that the US Food and Drug Administration (FDA) has expanded the use of its Deep Transcranial Magnetic Stimulation system (Deep TMS™) to treat major depressive disorder (MDD) in patients aged 22 to 86. Previously, the device was only approved for use in patients aged 22 to 68, but this new approval makes Deep TMS the first and only treatment available for older adults suffering from MDD, even when anxiety symptoms are present. The FDA’s decision was based on strong clinical data showing that the deeper, broader stimulation offered by Deep TMS can effectively target brain areas affected by age-related changes. This expanded indication reflects the growing need for advanced treatments as life expectancy increases and offers new hope for a broader range of patients battling depression.
Read Announcement
Deep TMS 360 FDA Regulatory Events
Deep TMS 360 is a drug developed by Brainsway for the following indication: In Patients With Alcohol Use Disorder.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Deep TMS 360
- Announced Date:
- November 17, 2025
- Indication:
- In Patients With Alcohol Use Disorder
Announcement
BrainsWay Ltd. announced the launch of a multicenter clinical trial investigating the use of its novel Deep TMS 360™ system in individuals with Alcohol Use Disorder (AUD).
AI Summary
BrainsWay Ltd. announced a multicenter clinical trial of its new Deep TMS 360™ system to treat Alcohol Use Disorder (AUD). The Deep TMS 360 is a next‑generation, multichannel transcranial magnetic stimulation platform designed to give more comprehensive, uniform stimulation to targeted brain regions. BrainsWay says the system may be better suited for complex cases, including people with cortical atrophy, and could help reduce alcohol cravings and support long‑term recovery.
The randomized, double‑blind, sham‑controlled trial will enroll more than 200 adults (ages 18–86) with moderate to severe AUD. Participants will receive active or sham treatments over about six months, with an intensive 3–5 week phase followed by weekly maintenance sessions and two sessions per visit. The main outcome is the share of participants with no heavy drinking days during the initial four months. Behavioral and educational coping sessions will also be provided. Study sites include multiple U.S. states and select locations in Israel and Sweden.
Read Announcement
