Imaging Biometrics announced it has received FDA 510(k) clearance by the Food and Drug Administration for the company’s new magnetic resonance imaging (MRI) perfusion software, IB Neuro(TM).

Imaging Biometrics, LLC (IB), a provider of advanced visualization and analytical software solutions, announced it has received FDA 510(k) clearance by the Food and Drug Administration for the company’s new magnetic resonance imaging (MRI) perfusion software, IB Neuro™.

By incorporating proprietary computational algorithms, IB Neuro™ enables clinicians to make informed decisions in their approach to MRI perfusion imaging of brain tumors and other brain disorders. Based on over ten years of award-winning research, the technology within IB Neuro™ has proven to be a robust way of providing more specific information about brain tumor biology and vasculature, enabled by the unique way it accounts for correcting contrast-agent leakage effects. Until now, most of the available dynamic susceptibility contrast (DSC) post-processing software tools did not correct for these leakage effects and, as a result, provided widely varying results.

“When comparing the results of other MR perfusion techniques against IB Neuro™, IB Neuro™ showed a statistically significant ability to consistently differentiate between normal and abnormal brain tissue, whereas all the other techniques to which IB Neuro™ was compared did not,” said Michael Schmainda, IB’s President and CEO. “This rich information should enable clinicians to better personalize care for patients with brain tumors and other brain disorders.”

IB Neuro™ generates and displays an array of perfusion parameter colormaps in just seconds. That’s a drastic improvement over the hour-plus time typically required to process the data sets using research laboratory software. Now neurosurgeons, neuroradiologists, neuro-oncologists and technologists can efficiently generate these perfusion maps in a few simple mouse-clicks.

Beta versions of IB Neuro™ have already been licensed for research purposes to more than two dozen institutions around the world and can also assist pharmaceutical companies in the development of new therapies. IB Neuro™ is currently available as an OsiriX plug-in. OsiriX is an open-source, image processing software, designed for navigation and visualization of multimodality and multidimensional images.