Just Say No: FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull

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.

via Press Announcements > FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull.

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).


Comments

  1. One paper referenced on their web site said it took “less than 10 minutes” to perform. Not on the top of our wish list just yet.

  2. Baruch Ben-Dor says:

    From the company: The Infrascanner is an early screening tool and not a replacement for a CT scanner, and hence sensitivity less than 100% is perfectly fine. Furthermore the FDA always tries to present the data in the worst possible way. Please look for yourself at the published data, which is much better (close to 90% sensitivity and 90% specificity):
    Robertson, C., Zager, E., Narayan, R., Handly, N., Sharma, A., Hanley, D., Garza, H., Maloney-Wilensky, E., Plaum, J., and Koenig, C., 2010, “Clinical Evaluation of a Portable Near-Infrared Device for Detection of Traumatic Intracranial Hematomas,” Journal of Neurotrauma, 27(9), pp. 1597-1604.
    Leon-Carrion, J., Dominguez-Roldan, J., Leon-Dominguez, U., and Murillo-Cabezas, F., 2010, “The Infrascanner, a handheld device for screening in situ for the presence of brain haematomas,” Brain Injury, 24(10), pp. 1193-1201.

  3. Baruch Ben-Dor says:

    Regarding scan time – Thanks for the catch, we need to update our website. This is an old info, and our studies showed that full head scan is one to two minutes.

  4. Okay, thanks for the response.

    But, if it’s not a replacement for a CT scanner, what’s its use?

Trackbacks

  1. [...] GruntDoc commented on this earlier, but I had to mention it now since it was just released as one of the top 10 articles on Medscape. The FDA has given approval to a device called an “Infrascanner” to detect intracranial bleeding. The device can detect “nearly 75%” of hematomas detected by CT scan. Hematomas don’t include deeper bleeding, so I’m assuming that these results don’t include subarachnoid hemorrhages or intraparenchymal bleeds. The device also excludes hematomas 82% of the time, meaning that the unfortunate 18% of patients are going to get a burr hole drilled in their head for bleeding that the Infrascanner says is present when it is really not. Or they’ll just get a CT scan which makes the whole Infrascanner thing a waste of time and money. However, I am developing a similar device for which I will soon seek approval from the FDA. A prototype is pictured at the right. [...]