BX Pulsar 1002 – LIFUP Neuromodulation Console

The BX Pulsar 1002 is our flagship focused ultrasound neuromodulation device. This console is the “brains” of the system, containing the electronics and software that generate and control the ultrasound pulses delivered to the patient. The BX Pulsar 1002 is an integrated, all-in-one ultrasound stimulation unit – essentially a specialized computer with a built-in ultrasonic waveform generator and amplifier. It features a user-friendly interface with proprietary BrainSonix software for configuring stimulation parameters and monitoring sessions. Researchers or clinicians can select from preset pulse sequence protocols or customize parameters such as pulse width, pulse repetition frequency, duty cycle, intensity, and total sonication duration. Once the desired settings are entered, the system automatically computes the required drive voltage and other outputs to achieve those acoustic settings, taking into account the transducer’s calibration data. The console provides real-time feedback and ensures that the delivered ultrasound dose matches the prescribed values.

Notably, the BX Pulsar 1002 was designed to be fully MRI-compatible and MR-safe, enabling its use in conjunction with MR neuroimaging up to 3T. In practice, this means a subject can be inside an MRI scanner bore with the ultrasound transducer on their head while the console (connected via a long cable and wall filter) operates in the control room – allowing simultaneous fMRI and ultrasound stimulation experiments. The system’s electronics have been tested to ensure they do not interfere with MRI scanning and vice versa. The device is also relatively portable (a tabletop unit) so it can be moved between lab or clinic rooms as needed.

Safety features of the BX Pulsar 1002 include automatic shutdown if any parameter exceeds predefined safety limits, emergency stop controls (both software and a physical emergency stop button on the console), and continuous self-monitoring for faults (with indicators for power status and any errors). The hardware is built to medical-grade standards (IEC 60601 compliant for electrical safety and electromagnetic emissions).

Regulatory status: The BX Pulsar 1002 is currently designated as a Research Use Only / Investigational device in the United States – its use is limited to IRB-approved studies under an FDA Investigational Device Exemption (IDE) at this time. (It is not yet FDA-cleared for general clinical practice.) As such, it is primarily supplied to research institutions, universities, and clinical trial sites. We are actively working through clinical trials to gather data with the goal of achieving regulatory approvals for specific therapeutic indications in the future. In the meantime, the BX Pulsar 1002 has already been deployed in multiple human studies (in areas like brain mapping, disorders of consciousness, depression, chronic pain, etc.) and has proven to be a robust and reliable platform for advancing focused ultrasound therapy.