Turing Medical, a firm developing precision brain mapping and targeting technologies, has announced that its Bullsai Identify platform has received 510(k) clearance from the US Food and Drug Administration (FDA).
Bullsai Identify is claimed to be an advanced, automated end-to-end solution. It is designed to deliver precise, personalised data for neuromodulation therapy planning in neurological conditions like Parkinson’s disease and essential tremor.
The platform integrates smoothly into clinical workflows, providing essential insights into individual brain locations to assist clinicians in developing tailored treatment plans.
Bullsai Identify uses advanced imaging and algorithms to create detailed, patient-specific brain maps, compared to traditional methods that depend on generalised brain anatomy.
According to Chicago-based Turing Medical, the approach allows physicians to pinpoint optimal targets for neuromodulation therapies such as deep brain stimulation (DBS) and focused ultrasound (FUS) with more accuracy.
By incorporating personalised data into clinical workflows, the platform seeks to enhance therapy outcomes, minimise off-target effects, and reduce recovery times.
Turing Medical president and CEO Ken Bruener said: “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,”
“Our automated platform can optimise treatment planning and help establish a new standard of care for neurological conditions.”
By utilising advanced MRI processing techniques, Bullsai Identify integrates anatomical and connectivity data to produce detailed brain maps.
These maps assist clinicians in creating tailored treatment strategies that are specific to each patient.
Turing Medical is partnering with hospitals, academic institutions, and clinics to roll out this technology and collect crucial feedback for future advancements.
Other products in Turing Medical’s portfolio include Bullsai Enhance and Bullsai Confirm. The firm also has research-based platforms including FIRMM and FIRMM-PIX.
The FIRMM software received the FDA 510(k) clearance in 2021. FIRMM offers real-time monitoring and biofeedback to tackle the major issue of patient movement during brain MRI scans.
FIRMM-PIX was launched in June 2023 to offer enhanced image acquisition efficiency and data quality.
