Aidoc, an Israeli company specializes in providing artificial intelligence (AI) support for radiologists had obtained a clearance from the US Food and Drug Administration (FDA) for its Pulmonary Embolism (PE) solution, as the company announced in a press release today (15 May).
The PE solution will work alongside with radiologists to flag PE cases in chest computed tomography (CT) scans. The PE solution is part of Aidoc’s expanding suite of AI-based workflow orchestration solution. This approval comes just weeks after the company had closed a $27 million funding round, bringing its total funding to $40 million.
Primarily, Aidoc’s solutions analyze medical images directly after the patient is scanned. Radiologists will be alerted shall there be any suspicious findings to ensure the prioritization of time-sensitive and potentially life-threatening cases. Aidoc’s solutions have successfully shortened the time from scan to diagnosis for some patients from hours to under five minutes. This, in turn, speeds up the process of treatment and improving prognosis.
The challenges in obtaining approval
This is not the first breakthrough Aidoc has. Last August, the company also became the first in the World to receive FDA clearance to enable radiologists to triage patients using AI. The clearance allows Aidoc’s brain solution to work with radiologists to flag acute intracranial hemorrhage (ICH) cases in head CT scans. It is also the pioneer deep learning solution to back radiologists in their workflow triage.
For that, AIMed had spoken with Arielle Shoham, Aidoc’s Vice-President of Marketing on the challenges of obtaining FDA approval at the recent European Congress of Radiology (ECR) 2019 in Vienna. Shoham expressed newness is exactly the issue which makes approval seeking a challenge. FDA has a tradition of approving concrete devices or medication. Yet, technology is rather fluid. At the rate it is evolving, having a regulation to keep up with technological advancement or vice versa, has become incredibly tricky. It is important to find the right balance.
So, what Aidoc does is, according to Shoham, decide on the category with the FDA that is the most suitable. The company has settled on triaging or AI-based triage for radiologists of intracranial images. “I think it’s important to define how you will like to work clearly with the FDA and set the kind of metrics or protocols they will like to see,” said Shoham.
The process could be time-consuming. On one hand, FDA is continuously updating its criteria. As seen in the introduction of the pre-cert pilot program, 510(k) premarket notification, and a tailored framework for AI-based devices. On the other hand, the company has to ensure its gold standard. “We run clinical studies with various facilities, ensuring everything is of gold standard,” Shoham said.
The meaning of this new clearance
PE has found to be the cause of up to 200,000 deaths each year in the US. Undetected or late-diagnosis is often one of the most common leads to preventable death among hospitalized patients. Diagnosing PE can be a perplexing task for healthcare professionals because of its variability and non-specific presentation. This has provided AI a leeway to step in to reassure the benefits of AI-driven workflow triage.
In the press release, Daniel J. Durand, Chair of Radiology at LifeBridge Health said, “it is clear that AI will play a tremendous role in the future of radiology. Considering the complexity of vascular diagnosis, we are eager to see how Aidoc’s solutions can benefit out pulmonary embolism patients and bring tomorrow’s technology to LifeBridge Health, today.” Elad Walach, co-founder and Chief Executive Officer of Aidoc added, “What really excites us about this clearance is that it paves the way towards scalable product expansion. 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 am excited about what will come next.”