FDA Events for Brainsway (BWAY)
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. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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- Drug:
- Deep TMS
- Announced Date:
- April 17, 2024
- Indication:
- Decreasing Anxiety Symptoms in Depressed Patients
Announcement
BrainsWay Ltd announced the further expansion of access to its Deep TMS™ treatment in Israel.
AI Summary
BrainsWay Ltd. announced the expansion of access to its Deep TMS™ treatment in Israel. The company, known for its noninvasive neurostimulation solutions, has recently installed 11 new systems across the country. This expansion is supported by a 45% increase in reimbursement rates, which has helped the company reach more patients. BrainsWay is planning even more installations by the end of 2024.
Hadar Levy, CEO of BrainsWay, mentioned that offering Deep TMS therapy is very important, especially now as mental health conditions have become more serious in Israel due to recent events. Reut Filipowicz, the Head of Business Development for the Israeli market, added that the innovative treatment provides hope to patients who have not found relief through medication. The expansion underscores BrainsWay’s commitment to improving mental health care both locally and worldwide.
Read Announcement- Drug:
- Deep TMS
- Announced Date:
- April 4, 2024
- Indication:
- Decreasing Anxiety Symptoms in Depressed Patients
Announcement
BrainsWay Ltd. announced results published in a review article exploring the potential efficacy of Deep Transcranial Magnetic Stimulation (Deep TMS™) as a novel therapeutic approach for Parkinson's Disease (PD).
Read Announcement
Brainsway FDA Events - Frequently Asked Questions
As of now, Brainsway (BWAY) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Brainsway (BWAY) has reported FDA regulatory activity for Deep TMS.
The most recent FDA-related event for Brainsway occurred on June 11, 2025, involving Deep TMS. The update was categorized as "Preliminary Results," with the company reporting: "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.""
Currently, Brainsway has one therapy (Deep TMS) targeting the following condition: Decreasing Anxiety Symptoms in Depressed Patients.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:BWAY) was last updated on 7/11/2025 by MarketBeat.com Staff
