Rowan-based startup receives FDA clearance for medical technology

Rowan-based startup receives FDA clearance for medical technology

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November 12, 2024
Nidhal Bouaynaya co-founded MRIMath, LLC, in 2017.

A cloud-based, artificial intelligence-powered medical innovation, jointly patented by Rowan University and the University of Alabama at Birmingham to speed the mapping and measurement of glioblastoma brain tumors, has received clearance from the Food and Drug Administration. The regulatory decision means its makers at MRIMath, LLC are permitted to market the tool to potential customers. A black-and-white image of an MRI brain scan shows an irregular shaped tumor in red.

The medical technology company was co-founded in 2017 by Nidhal C. Bouaynaya, Ph.D., professor of electrical and computer engineering and associate dean for research and graduate studies at Rowan University, and Hassan Fathallah-Shaykh, M.D., Ph.D., a neuro-oncologist and mathematician at the University of Alabama at Birmingham.

Their cyber tool, called MRIMath i2Contour, is designed to improve efficiency and accuracy, saving physicians hours per imaging study, according to the company, while “significantly reducing bottlenecks in contouring and accelerating patient care.” As a result, the device has the potential to improve patient outcomes and reduce health care costs. 

Glioblastoma tumors are the most common primary brain tumors in adults—and the most deadly. Trained on a vast dataset of MRI images, i2Contour delineates the tumor boundaries with pixel-level accuracy, and assesses previous radiological scans to calculate tumor volume and predict growth trend using a statistical method. This enables physicians to detect and respond to tumor development earlier.   

Universities and hospital systems have expressed interest in the product, Bouaynaya said.

“It’s incredibly challenging to anticipate tumor characteristics, such as location, volume and shape, as it evolves,” Bouaynaya said. “AI is the best system for this level of complexity, as it can analyze vast amounts of data to accurately predict tumor characteristics.” 

MRIMath, LLC, received support from the Rowan Innovation Venture Fund, the National Institutes of Health Small Business Innovation Research (SBIR) program (Phases I and II), the National Science Foundation’s Innovation Corps, the New Jersey Commission on Science and Technology and the Innovate Alabama award.