Brand Name Only BrainsWay_Redacted.pdf
PDF 270 KB Posted
- Attached to
- BrainsWay Deep TMS System
- Solicitation number
- 36C26126Q0894
About this file
This document is a Justification for Single Source Awards under IAW RFO 12.102(a) for purchases exceeding the micro-purchase threshold but not exceeding the Simplified Acquisition Threshold (SAT), issued by the Department of Veterans Affairs Network Contracting Office (NCO) 21 at the Palo Alto VA Medical Center on 12/30/2025 (Revision 02).
The VA is procuring a BrainsWay Deep Repetitive Transcranial Magnetic Stimulation (rTMS) device system and accessories for clinical use. The specific items required include: Deep TMS System 104 With H4 (part SYS-104-008), Upgrade Kit H7-Rct for 104 (part SYS-104-131), Third Arm For Cart 104-H1 (part SYS-104-301), and a System Service Contract for 1 Year (part SVS), with one unit of each item. The justification establishes that only the BrainsWay 104 with H4 Deep TMS System meets the clinical and technical requirements, including FDA clearance for advanced research protocols, support for OCD and smoking cessation treatment, unique H-Coil technology, and specified technical parameters including 10Hz pulse frequency, 37.5-minute treatment duration, and 90,000 total pulses for 30 sessions. Market research via Adds Up, FDA Device Registry, Google search, GSA Advantage, and VA Supply Chain Master Catalog confirmed that the H-coil technology is unique to BrainsWay and not replicated in any other FDA-cleared rTMS device. BrainsWay operates as the original equipment manufacturer with one authorized small business distributor, qualifying this as a competitive Brand Name Only requirement meeting the Rule of Two. The Contracting Officer certified approval under RFO 12.102(a).
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Revision: 02 Effective Date: 12/30/2025 Page 2 of 2 Acquisition ID#
4. Description of market research conducted and results or statement why it was not conducted: Research was conducted via review of the BrainsWay device on Adds Up and the FDA Device Registry. A Google search (google.com) was utilized to confirm that while the FDA Registry locates other rTMS devices, the H-coil is unique to BrainsWay and is not replicated in any other known, FDA cleared device.
Adds Up showed awards only to the Original Equipment Manufacturer (OEM), BrainsWay. GSA Advantage and VA Supply Chain Master Catalog were searched but resulted in no existing contacts offering the necessary device or services.
BrainsWay has confirmed via email on 6/26/2026 that in addition to direct sales to the Government, they have one authorized distributor, a small business. This shall be a competitive, Brand Name Only requirement. The Rule of Two has been met.
The Non-Manufacturer Rule applies only to socio-economic set asides under the Simplified Acquisition Threshold.
5. Contracting Officer's Certification: Purchase is approved in accordance with RFO
12.102(a). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.
File details come from the government source that posted it. Updated .