FDA Gives Aidoc Clearance for AI

Israeli startup Aidoc, which has developed AI-powered software for analyzing medical images, has received regulatory clearance from the FDA. Thanks to this clearance, it will be able to use its AI solution commercially for flagging and communicating incidental pulmonary embolism. According to Aidoc, this clearance from the FDA is a first for the industry for an AI software of this type. 

Established in 2016, the startup has come up with a medical imaging software for the full-body, which has been designed for detecting and highlighting critical anomalies for assisting radiologists. It accomplishes this goal through AI algorithms and deep learning. A quick analysis of medical scans is performed for helping doctors in prioritizing patients and their care. This is the sixth FDA clearance that the company has received and it joins other tools cleared by them for the notification and triage of Pulmonary Embolism (PE), spine fractures, and strokes in brain hemorrhages and chest scans. 

In May, Aidoc had received approval from the FDA for using its AI algorithms for detecting findings related to COVID-19. A sudden blockage that happens in a lung artery is defined as a pulmonary embolism. Even though Aidoc said that flagging these incidents is a major technical challenge, but using the numerous imaging protocols and can help in lowering the incidence of such cases. The company said that it was a ‘breakthrough’ to be able to highlight incidental critical conditions with such accuracy and also gives a safety net for any unexpected cases. 

Michael Braginsky, Elad Walach, and Guy Reiner founded Aidoc. The three of them graduated from Talpiot, the elite Israeli program that focuses on recruits who possess advanced abilities in the field of science and technology to become experts in research and development. To date, the company has managed to raise funding of about $60 million, which includes the $20 million they had accumulated just last month. The solutions introduced by the company have been put in clinical use in five continents and at nearly 400 health centers.