BRAINSWAY DEEP TMS SYSTEM

This is a notice of intent to sole source a contract under the authority of RFO FAR 12.102, only one source being available to meet the Government’s need.  The contract is estimated for final completion by 08/31/2027.

The North American Industrial Classification System (NAICS) code for this procurement is 339112, Surgical and Medical Instrument Manufacturing, with a small business size standard of 1,000 employees.  The PSC is 6515 for Medical and Surgical Instruments, Equipment, and Supplies.

The Department of Veterans Affairs intends to solicit a  firm fixed price order for a BrainsWay Deep TMS System 104 with Accessories and initial Services with BrainsWay USA Inc, 300 Knickerbocker Rd Ste 2300, NJ 07626. There are no other sources that will satisfy agency requirements for the necessary equipment.  Only BrainsWay has developed and received FDA clearance on the necessary H-coil technology.  Only the BrainsWay 104 with H4 Deep TMS System is known capable of meeting all the necessary salients and technical functions of this requirement.  BrainsWay has confirmed they have no authorized distributors for the necessary equipment.

Any responsible source that feels it is capable in performing this requirement may submit a quote for the listed items from the solicitation and describe and/or submit documentation to support your capabilities.  The response will be considered by the agency.  Responses should be submitted to Leah Smith at leah.smith@va.gov no later than Wednesday, June 24th, 2026, at 11:00 AM Pacific Time, to be considered. The Government will not pay for information submitted. Any responses received will only be considered for the purposes of determining whether to conduct a competitive procurement in lieu of sole source contract described in this notice, and such determination shall be made at the sole discretion of the Government. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the requirement. If no responses are received, the government will proceed with the Sole Source acquisition.