Turing Medical's Bullsai Identify Secures FDA Clearance: Ushering in A New Era of Precision Brain Mapping for Neuromodulation Therapy

Ashley King, VP, Sales and Business Development
Ashley.king@turingmedical.com

Turing Medical, a leader in precision brain mapping and targeting technologies, announced today that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Bullsai Identify platform. Bullsai Identify is an advanced, automated end-to-end platform and mapping solution that provides personalized, precise data to support decision-making in planning for neuromodulation therapies for neurological disorders, such as Parkinson’s disease and essential tremor. This innovative platform integrates seamlessly with clinical workflows, offering critical insights into patient-specific brain locations to aid clinicians in their treatment planning.

“We are thrilled about the FDA clearance of Bullsai Identify, as it represents a major advancement for both Turing Medical and the field of neuromodulation,” said Ken Bruener, President and CEO of Turing Medical. “Our automated platform can optimize treatment planning and help establish a new standard of care for neurological conditions.”

Bullsai Identify: Setting a New Standard in Neuromodulation

Unlike traditional methods that rely on generalized brain anatomy, Bullsai Identify uses advanced imaging and algorithms to generate detailed, patient-specific brain maps. This cutting-edge approach enables physicians to more accurately identify optimal targets for neuromodulation therapies like Deep Brain Stimulation (DBS) and Focused Ultrasound (FUS). By integrating personalized data into clinical workflows, Bullsai Identify aims to improve therapy outcomes, reduce off-target effects, and shorten recovery times.

“Bullsai Identify’s personalized approach to brain mapping takes into account each patient's unique brain structure and connectivity, offering the potential for better-targeted, more effective treatments,” said Dr. Leo Sugrue, a medical advisor at Turing Medical and associate professor of radiology and biomedical imaging at UCSF. “This can lead to more accurate therapies, fewer side effects, and ultimately, better clinical outcomes.”

Technology Impact and Future Directions

By leveraging advanced MRI processing techniques, Bullsai Identify incorporates anatomical and connectivity data to generate highly detailed brain maps which support clinicians in developing patient-specific treatment strategies. “We see this FDA clearance as a validation of our automated precision medicine approach, which aims to make advanced brain mapping accessible and impactful for all clinical care settings,” added Dr. Damien Fair, co-founder of Turing Medical. “Bullsai Identify's ability to provide detailed, patient-specific insights will help clinicians make more informed decisions, ultimately improving quality of life for those affected by neurodegenerative and neuropsychiatric disorders as well.”

Commercial Launch

This week, Turing Medical launched Bullsai Identify at the World Society of Stereotactic and Functional Neurosurgery (WSSFN) conference. The company is collaborating with leading hospitals, teaching institutions, and clinics to introduce this innovative technology and gather valuable insights for future product development.

About Turing Medical

Turing Medical is at the forefront of neurotechnology, committed to transforming neuromodulation therapies by delivering precise, personalized targeting solutions. By seamlessly integrating advanced neuroimaging into clinical workflows, Turing Medical aims to redefine the standard of care, improve patient outcomes, and minimize off-target effects in both invasive and non-invasive treatments.

For more information, visit Turing Medical Website.