TDi receives FDA 510(k) clearance for ultrasound platform

15 April 2020 (Last Updated April 15th, 2020 13:57)

Tissue Differentiation Intelligence (TDi) has received 510(k) clearance from the US Food and Drug Administration for its SonoVision ultrasound platform that provides intraoperative access to the spine.

TDi receives FDA 510(k) clearance for ultrasound platform
The SonoVision electronics platform displays an axial psoas muscle image with intuitive color differentiation of nerve, muscle and bone. Source: Tissue Differentiation Intelligence.

Tissue Differentiation Intelligence (TDi) has received 510(k) clearance from the US Food and Drug Administration for its SonoVision ultrasound platform that provides intraoperative access to the spine.

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

It can now be used as a new imaging modality for spine surgery by overcoming the impracticalities of conventional ultrasound.

TDi Chairman and CEO Alex Lukianov said: “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.”

Currently, the company has multiple systems deployed for clinical study data collection under IRB and for Alpha evaluations. They are focused 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.

Meanwhile, TDi has also received intellectual property for the algorithm and procedural applications.

It protects ultrasonically scanning tissue, interpreting images through signal and image processing, and algorithms used while differentiating tissue based on image characteristics and spectral signatures.

Recently, TDi has completed an in-vivo porcine study validating the accuracy of SonoVision.