Mass High Tech is reporting that Optasia Medical out of Sudbury, MA received 510(k) clearance from the FDA for its SpineAnalyzer X-ray analysis software. The system can help identify deformed vertebrae between T4 and L4.
About the SpineAnalyzer from the product page:
SpineAnalyzer™ helps identify even subtle vertebral deformities by efficiently and comprehensively annotating spinal anatomy. This unique software workflow solution enables rapid and reproducible assessment of the accepted quantitative standard (6-point morphometry), by providing full, easily editable contours outlining vertebral shape. The software employs a proprietary statistical model-based image analysis technique, which uses simple manual single-point initialization to automatically segment the lateral vertebral margins of the spine on selected vertebrae from T4 to L4. SpineAnalyzer™ produces a report that shows deformed vertebrae and permits the physician to compare these to a report from other time-points.
Annotating vertebraeDeformity results table Workflow facilitation
SpineAnalyzer™ is designed to fit seamlessly into the existing workflow of scoring lateral spine images for vertebral deformity. On a PC with access to the x-ray or VFA (DXA) images from either PACS, DICOMDIR or network files, the clinician performs the following steps:
* Selects patient and displays lateral spine x-ray or VFA images.
* With a single click per vertebra, labels the vertebrae of interest. Any vertebrae between T4 and L4 can be analyzed.
SpineAnalyzer™ then performs the following steps:
* Automatically annotates vertebral body margins and places points for 6-point morphometry.
* Allows clinician to review validity of annotations and make corrections as needed.
* Grades the severity of deformity.
* Facilitates the reporting of SQ scoring and differential diagnosis.
* Produces a PDF format report and allows optional export of analysis data.
Product page: SpineAnalyzer...
Mass High Tech: Optasia gets FDA clearance on spinal imaging analyzer...