BrainsWay said the FDA cleared an accelerated Deep TMS protocol for major depressive disorder, with an acute phase of six treatment days rather than four weeks in the previous schedule.
FDA clearance announced
According to BrainsWay via GlobeNewswire, the company received FDA clearance for an accelerated protocol used with its Deep TMS system. The source describes the treatment as non-invasive and says the protocol is for major depressive disorder, including patients with comorbid anxiety.
BrainsWay, which the source says has offices in Burlington, Massachusetts, announced the clearance. The announcement concerns the company’s Deep TMS system and does not identify Massachusetts treatment locations offering the accelerated protocol.
A six-day acute phase
According to the announcement, the previous treatment schedule involved daily sessions over four weeks. BrainsWay said the newly cleared accelerated protocol includes an acute phase lasting six treatment days.
The source does not provide a session count per day, a detailed calendar for the six days, or further scheduling specifications. It also does not say whether the schedule differs for people with major depressive disorder and comorbid anxiety.
Company cites comparable findings
BrainsWay said clinical data showed results comparable to standard Deep TMS in improvement, response and remission. The supplied announcement does not provide numerical findings, participant details, or study-method information.
The company’s statement presents the accelerated protocol as a shorter acute-phase option compared with the earlier four-week daily-session schedule. It does not provide further detail on the clinical data cited.
Training and reimbursement plans
According to BrainsWay, the company plans to train providers in the coming months. It also said it would seek reimbursement updates.
The announcement does not provide a completion date for provider training or details about potential reimbursement changes. It also does not identify which providers may receive training or when the accelerated protocol may be available in particular locations.
What this means for Massachusetts patients
For Massachusetts patients trying to find treatment locally, the announcement may be useful background when comparing available treatment information. The directory lists 146 published clinics in Massachusetts, but the source does not say which, if any, locations offer this accelerated protocol. Local provider listings may help patients identify treatment options and ask about the training described by BrainsWay.
This is general information, not medical advice.
More Massachusetts reporting on treatment updates.
This report is educational and is not medical advice. Coverage, availability and eligibility can change; verify details with the named source or your care team.