I read that headline and said, “Wow!, finally I won’t need to CT all those patients’ heads!”
FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull
Helps to determine if immediate CT scan is needed
The U.S. Food and Drug Administration today allowed marketing of the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas, using near-infrared spectroscopy.
But then, wait, said I, is it any good? Apparently Not:
The FDA granted the de novo petition for the Infrascanner Model 1000 based on a review of data comparing results from 383 CT scans of adult subjects with Infrascanner scan results. The Infrascanner was able to detect nearly 75 percent of the hematomas detected by CT scan. When CT scans detected no hematoma, the Infrascanner detected no hematoma 82 percent of the time. The Infrascanner Model 1000, however, is not a substitute for a CT scan.
Anyone considering purchasing one of these based on those numbers? If so, I’ll sell you a random number generator for 1/2 of what they’re asking.
Stated another way, this device will miss more than 25% of intracranial hematomas that are present, and will tell you it’s there when it’s not 18% of the time.
Not ready for prime time. I feel bad for the detailers who are sent out to see this thing, and worse for the patients it’s used on.
Brought to my attention by @EMNews on twitter. (In case you missed it, I’m getting a lot of my bloggable stuff from Twitter. I don’t blog most of what I comment on. Imagine what you’re missing! Get to twitter, and follow me @gruntdoc).