RapidAI Receives FDA 510(k) Clearance for Pulmonary Embolism Triage & Notification

RapidAI announced that it has received FDA 510(k) clearance for its Rapid PE Triage & Notification product for fast identification and communication of suspected central pulmonary embolism — further strengthening RapidAI’s industry-leading clinical AI platform.

New research shows that death rates for pulmonary embolism have been on the rise over the last decade, with the biggest increase among people under 65. For those who experience and survive a PE incident, one-third will have a recurrence within 10 years. Increasing access to clinically validated technology will be key to helping hospitals more efficiently coordinate care, make accurate diagnoses in a timely manner, and get PE patients to treatment faster, leading to better outcomes.

“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. “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. From stroke to aneurysm to PE, we’re proud of how much RapidAI has grown and are excited to continue to redefine the patient care journey.”

Rapid PE Triage & Notification, in conjunction with Rapid Workflow for PE, will enable care teams to more easily manage the entire patient care journey, from the moment a suspected PE patient is identified to diagnosis and through treatment. By automatically identifying a suspected pulmonary embolism and delivering real-time notifications to physicians, patients can be triaged faster and care teams aligned more quickly, reducing overall time to treatment.

“I’m excited to see first-hand how artificial intelligence will transform the way we triage and manage PE, a historically complicated process involving a diverse care team,” said Dr. Jimmy Kerrigan, an Interventional Cardiologist at Ascension St. Thomas Heart. “After seeing what RapidAI technology has done for stroke, I’m optimistic about its potential to optimize our care for patients and to hopefully improve patient outcomes.”