MedyMatch Technology Ltd., an Israeli startup whose software helps doctors give more accurate assessments about strokes and intracranial bleeds, said Monday it had been granted a special designation by the US Food and Drug Administration that will expedite the approval process for its technology.
The company said it has been granted Expedited Access Pathway and Breakthrough Device designation by the FDA for intracranial hemorrhage detection.
The software developed by the Tel Aviv-based startup, based on deep learning and artificial intelligence, can automatically analyze noncontrast head CT images, which are the standard scans used for the initial assessment of potential intracranial hemorrhages in hospitals and emergency rooms. Using algorithms, the software can pinpoint and alert physicians to the presence of ICH in these scans. This enables physicians to quickly determine if there is a bleed or not; time is of essence because during every minute that passes, brain cells die.
“This FDA designation is reserved for breakthrough devices — a new piece of technology that provides a solution to an unmet need,” said Gene Saragnese, the chairman and CEO of MedyMatch, in a phone interview. “Our technology is the first intracranial software to get this designation and we believe ours is the first application based on artificial intelligence to receive this breakthrough designation.”
“It means the technology we have developed is important,” he said. The ruling means that FDA officials will work closely with the company to help it through an expedited process toward approval.
“My expectation is that MedyMatch products will begin reaching the market in 2018,” he said.
The products will include apps that read CT images and help medics prioritize cases according to severity, and those that “provide a second read,” circling areas that could have an intracranial bleed, Saragnese said.
MedyMatch has already signed agreements with IBM Watson, GE Healthcare and Samsung Electronics, which have started integrating the software within their imaging solutions but are waiting for FDA and European approvals before starting use.
There are currently no automated tools in emergency or radiology departments to help physicians detect intracranial hemorrhage.
According to the American Heart Association and American Stroke Association (AHA/ASA), stroke is the fourth leading cause of death and one of the top causes of preventable disability in the United States. Affecting four percent of US adults, it is forecast that by 2030, there will be approximately 3.4 million stroke victims annually in the US, costing the healthcare system $240 billion a year.