RapidAI receives FDA 510(k) for another pulmonary embolism tool

RapidAI, a health tech company specializing in imaging analysis software, announced it received FDA 510(k) clearance for its Rapid RV/LV product that aims to speed up the pulmonary embolism triage and care process.

Rapid RV/LV analyzes Computerized Tomography Pulmonary Angiograms and calculates the ratio between the right ventricle and left ventricle after a scan. The difference in measurement can be a key indicator of the severity of pulmonary embolism, since about 45% of patients with acute pulmonary embolism will have acute right ventricle failure

The tool is a new addition to the company’s pulmonary embolism tools. Its use can be combined with RapidAI’s mobile and web apps dubbed Rapid Workflow and Rapid PE Triage & Notification platform, which analyzes CPTA images and alerts care teams when it finds a suspected pulmonary embolism.

“The FDA clearance of Rapid RV/LV further enhances our PE solution by providing physicians with an immediate view into patients suffering from RV strain, which is critical to getting the right patients to the right care as fast as possible. This is yet another step toward delivering AI-based solutions that help physicians further enhance patient care and impact patient outcomes to ultimately improve quality of life – something we are very proud to be part of,” Karim Karti, CEO of RapidAI, said in a statement.


After years of steady decline, the number of individuals who died from pulmonary embolism began increasing year over year, with the biggest increase in premature deaths occurring among those 65 years of age and younger. 

RapidAI, also known as iSchemaView, has several FDA 510(k) clearances, according to the FDA’s database

Some of its FDA 510(k) clearances include:

  • Its Rapid ASPECTS device that helps physicians detect brain injuries and determine if a patient is eligible for a thrombectomy. 
  • Its Rapid Hyperdensity platform, which allows physicians to assess the severity of injury in patients with acute neurological conditions like brain hemorrhages and traumatic brain injury.
  • Its updated intracranial hemorrhagic management tool Rapid ICH.  

In 2020, the company garnered $25 million in Series B investment and acquired cerebral aneurysm management platform EndoVantage.



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