510(k) clearance to TDi’s spine surgery platform

May 9, 2020 0 By FM

Tissue Differentiation Intelligence, LLC (TDi) has received 510(k) clearance for the company’s SonoVision ultrasound platform designed for intraoperative access to the spine.

By applying layers of image-processing algorithms to ultrasound images collected intraoperatively, the device visually differentiates nerve, muscle, bone and vessels in real-time. 

The US FDA clearance 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.

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, according to the company.