Tissue Differentiation Intelligence (TDi) has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for the SonoVision ultrasound platform, designed for intraoperative access to the spine.
SonoVision applies layers of image-processing algorithms to ultrasound images collected intraoperatively, which allows it to visually differentiate nerve, muscle, bone and vessels in real time. The FDA clearance of SonoVision paves the way for ultrasound to be used as a new imaging modality for spine surgery by overcoming the impracticalities of conventional ultrasound, TDi said in a press release.
“This is a monumental achievement for TDi which validates the rigour of the research and development process that has occurred over the past seven years to make this technology possible. With this clearance, TDi ushers in a new era of innovations related to soft tissue imaging in spine surgery, and really, the beginning of a much broader trend of artificial intelligence and machine learning being applied to satisfy challenging clinical requirements in spine surgery. Congratulations to the TDi team of engineers, and to Kevin Foley, Kern Singh and David Schwartz for achieving this pivotal milestone.” said Alex Lukianov, TDi chairman and CEO.
The company currently has multiple systems deployed for clinical study data collection under IRB and for Alpha evaluations, which are focused primarily on the clinical refinement of the lateral surgery access product. Expanded procedural applications, including posterior access to the spine, 3D imaging and image-guided navigation integration are also in earlier stages of procedural development.