FDA approves Aidoc's AI-powered detection of pulmonary embolism

"AI is quickly becoming established as the highest standard of care, helping doctors and saving patients' lives."

(From left) Aidoc founders Michael Braginsky, Elad Walach and Guy Reiner (photo credit: Courtesy)
(From left) Aidoc founders Michael Braginsky, Elad Walach and Guy Reiner
(photo credit: Courtesy)
Tel Aviv-based Aidoc has received US Food and Drug Administration approval for its artificial intelligence-powered solution to identify cases of pulmonary embolism in chest CT scans.
Up to 200,000 die annually due to pulmonary embolism, when a blood clot blocks an artery in the lung, in the United States alone. Undetected or late-detected pulmonary embolism is one of the most common causes of preventable death in hospitalized patients, with identification made challenging by variable and nonspecific symptoms at presentation.
Aidoc’s AI technology analyzes CT pulmonary angiograms immediately after the patient is scanned and notifies radiologists of suspected findings, enabling improved prioritization of time-sensitive and sometimes life-threatening cases.
The company says it can cut the time from scan to diagnosis from hours to under five minutes, thereby significantly improving patient prognosis.
“Thousands of US hospitals will now be able to use Aidoc’s new technology in a clinical setting, ensuring that patients with the most urgent, critical conditions like pulmonary embolisms are diagnosed and treated first,” Aidoc CEO and co-founder Elad Walach told The Jerusalem Post. “AI is quickly becoming established as the highest standard of care, helping doctors and saving patients’ lives.”
According to recent research published in March at the European Society of Radiology’s ECR 2019 Congress, Aidoc’s algorithm was found to have “high sensitivity and specificity,” and recorded a positive predictive value of 77% for the detection of pulmonary embolism.
“It is clear that AI will play a tremendous role in the future of radiology,” said Dr. Daniel J. Durand, chairman of radiology at Baltimore, Maryland-based LifeBridge Health. “Considering the complexity of vascular diagnosis, we are eager to see how Aidoc’s solutions can benefit our pulmonary embolism patients and bring tomorrow’s technology to LifeBridge Health, today.”
In August 2018, Aidoc also received Food and Drug Administration approval for its brain solution, which works with radiologists to flag acute intracranial hemorrhage cases in head CTs.
The company currently has eight more technologies in active clinical trials, as it seeks to introduce more of its AI-based range of solutions into the clinical setting. Its technology is currently deployed at over 100 medical centers and has reviewed in excess of one million scans.
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Last month, Aidoc secured a $27 million Series B investment, led by Square Peg Capital, bringing its total funding to $40m. The company hopes to reach 500 hospitals within two years.