FDA Approves Hand-Held Device that can Diagnose Intracranial Hematomas
- Infrascan out of Philly, PA has received FDA approval for its next generation Infrascanner, the Model 2000, a device for detecting intracranial hematomas. The Infrascanner is meant to be a simple, easy-to-use screening tool which can be used to identify high-risk patients which should undergo further work-up including CT. The handheld device uses near-infrared (NIR) technology to detect intracranial bleeding. Extra-vascular blood absorbs NIR light more than intra-vascular blood due to a higher concentration of hemoglobin in an acute hematoma compared to brain tissue. The Infrascanner measures the difference in NIR light absorption and provides a simple yes/no signal for whether bleeding is likely to be present.
The Infrascanner Model 2000 was developed based on the Model 1000, following specifications of the US Marine Corps. While the previous version of the Infrascanner consisted of a separate sensor and PDA, the Model 2000 integrates the processing, display and control functions into the sensor device. In addition the system was ruggedized for improved durability and regular AA batteries can now be used in addition to a rechargeable power pack.
Scanning a patient with the device takes about 2-3 minutes. It can detect hematomas greater than 3.5 cc in volume and up to 2.5 cm deep from the surface of the brain (or 3.5 cm from the skin surface). In a clinical study in patients with epidural, subdural and intracerebral hematomas, sensitivity was 88% and speci?city 90.7% making it a fairly reliable tool for triaging and prioritization but not a substitute for CT. Potential uses include screening of intoxicated patients in whom neurological evaluation is unreliable or impossible, frequent monitoring of in-hospital patients with head injury, after neurosurgical procedures, and monitoring for changes in already present intracranial hematomas between CT scans. In addition it may be helpful in athletes and on the battle?eld; the device has been ?eld tested in Iraq and Afghanistan.
Product page: The Infrascanner Model 2000…