FDA clears way for ClearRead CT Software
The first FDA cleared device demonstrating superior nodule detection performance and faster reading using a concurrent read
DAYTON, Ohio – September 19, 2016 – Riverain Technologies is committed to providing cutting edge software to aid the clinician in the efficient, effective early detection of lung disease. Today, Riverain Technologies announces ClearRead CT, a breakthrough nodule detection application, has received clearance from the Food and Drug Administration (FDA).
ClearRead CT is the only FDA cleared device to support concurrent reading, allowing for faster reading with proven superior automatic nodule detection performance for all primary nodule types, including: solid, sub-solid and ground glass nodules.
ClearRead CT, powered by acquisition normalization technology, provides an enterprise ready solution for the entire healthcare network. The technology seamlessly processes CT scans from a wide range of manufacturers and acquisition protocols and quickly installs into the clinical environment without the need for new hardware or customized tuning to specific devices or protocols.
ClearRead CT was evaluated in a multi-reader, multi-case clinical trial and showed radiologists achieved a 29% reduction in missed actionable nodules, while reducing reading time by 26%.
ClearRead CT is comprised of two powerful tools, ClearRead CT | Vessel Suppress and ClearRead CT | Detect. Deep learning enables the vessel suppression technology to assist both machine and humans in the detection and characterization of all primary nodule types, allowing for previously unattained nodule detection performance.
“Achieving high reading efficiency while maintaining accuracy is increasingly important given the burden placed on today’s radiologists. With more patients and increased data volume due to thinner sections, ClearRead CT offers a critical advantage.” said Steve Worrell, Riverain’s Chief Executive Officer. “The use of deep learning and other key technologies to suppress the vessels in CT scans proved to be essential in realizing a product capable of achieving the two competing objectives.”
ClearRead CT is available for sale in the United States, Canada and Europe.