Israeli Startup Receives FDA Approval for Computer-assisted Triage

Go-ahead given for product’s algorithm to identify acute intracranial hemorrhage cases in head CTs

From left: Aidoc founders Braginsky, Walach and Reiner.
Guy Shriber

Israeli startup Aidoc, which provides AI solutions for radiologists, announced on Wednesday that it was granted Food and Drug Administration clearance for the first product of its expanding line of AI-based workflow optimization solutions.

The clearance is in the category of computer assisted triage, given for its algorithm to identify acute intracranial hemorrhage cases in head CTs. Such hemorrhaging can be caused by a trauma such as a blow to the head or from brain aneurysm caused by excessively high blood pressure, and can lead to a stroke.

Aidoc’s system was developed with the goal of helping radiologists cope with increasing amounts of imaging. It is meant to be introduced into the work flow of emergency rooms and to flag for radiologists the most sensitive cases so they can prioritize their care.

“We started with head examinations, because general head CTs are the most common images in hospitals, particularly in ERs, because of the high risk of head injury and the lack of clinical indications of what’s going on inside,” Aidoc’s CEO Elad Walach told TheMarker.

The startup is also in the process of getting similar FDA approval for interpreting images in other areas of the body, including the spine, throat and stomach. The company's system is used in over 50 hospitals outside the U.S., interpreting over a million images annually. In Israel, Sheba Hospital uses the system. Wallach cofounded Aidoc in 2016 together with two comrades from the army’s Talpiyot program – Michael Braginsky and Guy Reiner. The startup, which has raised $13 million so far from TLB Partners, Magma Venture Parnters and Emerge, employs 40 people in Tel Aviv.

Aidoc is the fourth Israeli company to receive FDA approval in recent months, and the third in the field of imagery. Two weeks ago, Healthy.io received approval to use its smartphone camera to be used as clinical grade diagnostic device. Earlier in July, Zebra Medical Vision received approval for its algorithm for identifying calcium deposits to be used as a decision support tool.