RapidAI receives FDA 510(ok) for an additional pulmonary embolism device


RapidAI, a well being tech firm specializing in imaging evaluation software program, introduced it acquired FDA 510(ok) clearance for its Speedy RV/LV product that goals to hurry up the pulmonary embolism triage and care course of.

Speedy RV/LV analyzes Computerized Tomography Pulmonary Angiograms and calculates the ratio between the proper ventricle and left ventricle after a scan. The distinction in measurement generally is a key indicator of the severity of pulmonary embolism, since about 45% of sufferers with acute pulmonary embolism could have acute proper ventricle failure. 

The device is a brand new addition to the corporate’s pulmonary embolism instruments. Its use will be mixed with RapidAI’s cell and net apps dubbed Speedy Workflow and Speedy PE Triage & Notification platform, which analyzes CPTA pictures and alerts care groups when it finds a suspected pulmonary embolism.

“The FDA clearance of Speedy RV/LV additional enhances our PE answer by offering physicians with an instantaneous view into sufferers affected by RV pressure, which is crucial to getting the proper sufferers to the proper care as quick as potential. That is yet one more step towards delivering AI-based options that assist physicians additional improve affected person care and influence affected person outcomes to in the end enhance high quality of life – one thing we’re very proud to be a part of,” Karim Karti, CEO of RapidAI, mentioned in an announcement.


After years of regular decline, the variety of people who died from pulmonary embolism started rising yr over yr, with the largest enhance in untimely deaths occurring amongst these 65 years of age and youthful. 

RapidAI, also called iSchemaView, has a number of FDA 510(ok) clearances, in keeping with the FDA’s database. 

A few of its FDA 510(ok) clearances embrace:

  • Its Speedy ASPECTS gadget that helps physicians detect mind accidents and decide if a affected person is eligible for a thrombectomy. 
  • Its Speedy Hyperdensity platform, which permits physicians to evaluate the severity of harm in sufferers with acute neurological circumstances like mind hemorrhages and traumatic mind harm.
  • Its up to date intracranial hemorrhagic administration device Speedy ICH.  

In 2020, the corporate garnered $25 million in Sequence B funding and purchased cerebral aneurysm administration platform EndoVantage.


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