FDA OKs World’s First AI Solution for Flagging Pulmonary Embolism

Aidoc, the provider of AI solutions for radiologists, announced today that it was granted Food and Drug Administration (FDA) clearance for an additional product in its expanding suite of AI-based workflow orchestration solutions. The clearance is for Aidoc’s Pulmonary Embolism (PE) solution that works with radiologists to flag and triage PE cases in chest CTs. The approval comes just weeks after Aidoc closed a $27 million funding round, bringing its total funding to $40 million.
 
“In addition to the significant value provided to the department by Aidoc’s ICH solution, we recently added the PE module to the workflow,” said Dr. Pressman, Chair of Imaging at Cedars-Sinai Medical Center. “I was impressed by the fact that the coverage continuously grows, allowing us to add this product in the workflow of more radiologists, becoming part of our daily work. I was also pleased by the ability of the software to prioritize PE studies accurately.”

In the United States alone, Up to 200,000 people a year die due to PE. Undetected or late-detected PE is one of the most common causes of preventable death in hospitalized patients. PE diagnosis can be highly challenging due to its variable and non-specific presentation, making AI-driven workflow triage especially beneficial. Recent research published at ECR in Vienna further shows the accuracy and value Aidoc’s solution can provide.
 
“It is clear that AI will play a tremendous role in the future of radiology,” said Daniel J. Durand, M.D., Chair of Radiology at 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.” LifeBridge Health operates four hospitals in and around Baltimore, Md.
 
The new clearance, combined with Aidoc’s other proven solutions, gives Aidoc the most clearances for deep learning solutions in radiology and positions it firmly at the forefront of making AI standard of care.
 
“What really excites us about this clearance is that it paves the way towards scalable product expansion.” Elad Walach, Aidoc co-founder and CEO said, “We strive to provide our customers with comprehensive end-to-end solutions and have put a lot of effort in developing a scalable AI platform. It took us 18 months to get our first FDA clearance, 6 for the second one, and we have 8 more packages in active clinical trials, I’m excited about what will come next. I can only extend my utmost gratitude to the FDA for having open communication channels and working together with us on clearing many solutions in parallel.”
 
Aidoc’s solutions analyze medical images directly after the patient is scanned and notify the radiologists of cases with suspected findings to assist with prioritization of time-sensitive, and potentially life-threatening cases. Aidoc cuts the time from scan to diagnosis for some patients from hours to under five minutes, speeding up treatment and improving prognosis.