RapidAI gets FDA clearance for AI designed to detect pulmonary embolism


It typically starts with what’s called deep vein thrombosis, or a clot deep in the body—usually the leg—that breaks off and travels to the lung, causing a blockage in a lung artery. Called pulmonary embolism, the blockage can be deadly. But where time is of the essence, the company RapidAI announced Monday that it has received FDA clearance for a system that’s designed to help quickly identify PE and support treatment.

The San Mateo, California-based RapidAI provides clinical decision support with doctors also using its AI-enabled imaging software for treating stroke patients. Its newly FDA-cleared Rapid PE Triage & Notification is designed to automatically identify a suspected central pulmonary embolism—a possible clot that’s found in the main, or central, arteries in the lung. Then it delivers real-time notifications to physicians, so that patients can be triaged faster and care teams aligned more quickly, reducing overall time to treatment, according to the company.

RapidAI’s FDA-cleared Rapid PE Triage & Notification is being used in conjunction with its patient workflow solution for pulmonary embolism, Rapid Workflow for PE, to enable care teams to more easily manage the entire patient care journey,

Pulmonary embolisms and deep vein thrombosis, which typically causes PE, kill about 100,000 people in the U.S. each year, according to the Centers for Disease Control and Prevention; and research show death rates are increasing especially in patients over 65. Sudden death is the first “symptom” for one-quarter of those patients, according to the CDC, making it critical that PE is detected and treated quickly.

Although the exact number of people who experience PE or DVT isn’t known, it could affect as many as 900,000 annually; and one third have a recurrence of PE within 10 years, according to the CDC. Swift, accurate diagnosis and treatment—which range from medications like blood thinners to surgery to remove the clot—can help reduce complications such as leg swelling and pain for survivors.

“Building on our expertise in stroke, we’re confident this technology will help modernize PE care and meaningfully improve patient outcomes,” said Karim Karti, CEO of RapidAI, in a statement. “Our goal is to build solutions that address the specific challenges associated with treating various conditions, as well as the communication and workflow issues faced by hospitals globally.”

Other companies, too, are using AI to detect conditions like PE in the absence of symptoms to help expedite treatment.

Israel-based Aidoc has an FDA-cleared AI pulmonary embolism screening tool that’s designed to flag potential cases of PE that are incidentally detected in chest CT scans. The technology helps clinicians triage high risk patients so they can get care more quickly.

Photo: Egor Kulinich, Getty Images



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