FDA puts MedyMatch image analysis software on fast track

MedyMatch Technology’s intracranial hemorrhage detection software has landed a spot on the FDA’s expedited access pathway (EAP). The designation sets MedyMatch up to receive advice from the FDA as it goes about advancing the software toward a filing for approval.

Israel’s MedyMatch is applying deep learning technologies to the analysis of medical images. These images are sent via the cloud to the company, where its software analyzes them alongside other patient data. In the case of the fast-tracked software, the goal is to identify intracranial hemorrhages in noncontrast head CT images. These images are commonly used in first-line emergency assessments.

Improving the speed and accuracy of the detection of intracranial hemorrhages, while cutting the level of human effort needed to do so, could lead to better outcomes for patients and lower costs for healthcare systems. 

MedyMatch, a 2017 Fierce 15 winner, is still working to validate this idea. But, equipped with the FDA designation, it could cut the time it takes to get the software into the hands of doctors. 

“FDA's expedited access pathway and breakthrough device designation gives us the opportunity to accelerate the development and approval process of our intracranial hemorrhage software in the U.S.,” Joshua Schulman, Ph.D., VP of clinical, regulatory and quality affairs at MedyMatch, said in a statement.

The FDA designation is the latest in a series of boosts for MedyMatch. Since emerging from stealth in 2016, MedyMatch has entered into relationships with GE Healthcare, IBM and Samsung. The alliances give MedyMatch a chance to integrate its software into imaging technologies.