510(k) clearance given to product for use in real-time surgery.
Ultrasound can now be used real-time during spinal surgery. The Food & Drug Administration announced Tuesday it has awarded 510(k) clearance to TDi™ for its SonoVision™ ultrasound platform.
According to a company statement, SonoVision™ is the first machine learning-enabled ultrasound platform designed for intraoperative access to the spine.
“With this clearance, TDi™ ushers in a new era of innovations related to soft tissue imaging in spine surgery and the beginning of a much broader trend of artificial intelligence and machine learning being applied to satisfy challenging clinical requirements of spine surgery,” said Alex Kulianov, TDi™ chairman and chief executive officer.
SonoVision™ uses image-processing algorithms to differentiate between nerve, muscle, bone, and vessels during real-time. With FDA clearance, Kulianov said, it can be used as an imaging modality for spine surgery. Work is currently being done to develop expanded procedural applications, such as posterior access to the spine, 3D imaging, and image-guided navigation integration.
According to TDi™ officials, SonoVision™ will accelerate commercialization efforts in 2020.