The Food and Drug Administration is using its Expedited Access Pathway program, known as EAP, to enable Israel-based MedyMatch to bring new radiology clinical decision support technology to the United States for treatment of intracranial hemorrhage detection.
Provisions in the 21st Century Cures Act offer expedited reviews of new types of treatment that can facilitate rapid patient access to medical devices that demonstrate potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases.
The product uses artificial intelligence, 3D imaging and deep learning technology to support assessment of multiple clinical indications present in a patient being treated in the emergency department.
The FDA program “gives us the opportunity to accelerate the development and approval process of our intracranial hemorrhage software in the United States,” says Joshua Schulman, vice president of clinical, regulatory and quality affairs at MedyMatch. “We look forward to working with the FDA to bring the application to market quickly.”
First use of the technology will focus on stroke assessment in ambulances and other emergency vehicles equipped with CAT scan technology. The first step in assessment is to rule out presence of bleeding in the brain.
At the RSNA conference in last November, GE Healthcare announced it would integrate the MedyMatch artificial intelligence into GE’s CAT scan systems.
MedyMatch also has announced that it will integrate its technology with Samsung NueuroLogica’s medical imaging hardware in the acute care market. This will offer providers a “second read” capability to more quickly and accurately assess patients before they get to a hospital.
In addition to its headquarters in Israel, MedyMatch also has a facility in Andover, Mass. More information from the company was not immediately available.
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