FDA clears machine learning-enabled ultrasound platform for spine access
Click Here to Manage Email Alerts
Tissue Differentiation Intelligence LLC has received FDA 510(k) clearance for SonoVision, an ultrasound product designed for intraoperative access to the spine, according to a company press release.
The newly cleared platform from Tissue Differentiation Intelligence LLC (TDi) adds layers of image-processing algorithms to display an ultrasound with color differentiation of nerves, muscles and bones in real time, according to the release.
“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,” Alex Lukianov, TDi chair and CEO, said in the release. “This is a monumental achievement for TDi which validates the rigor of the research and development process that has occurred over the past 7 years to make this technology possible.”