Infra-scanner; Quick, Cheap & Easy Bedside Diagnosis of Brain Injury

Intuitive Surgical received FDA clearance and will be making available its Single-Site Instrumentation for performing laparoscopic robotic-assisted cholecystectomies.

The kit is used with the da Vinci Si robotic surgical system much like traditional multi-port surgeries, providing surgeons precise control and 3D high definition video at the console.  infrascanner-brain-diagnostics

Infrascanner™ is a hand-held, non-invasive, near-infrared (NIR) based mobile imaging device to detect brain hematoma at the site of injury within the “golden hour”. This refers to the period following head trauma when pre-hospital analysis is needed to rapidly assess the neurological condition of a victim.

The InfraScanner™ can be a practical solution to the problem of early identification of intracranial hematomas because of the unique light-absorbing properties of hemoglobin and the non-invasive, non-ionizing nature of NIR technology. The basic method for Hematoma detection is based on the differential light absorption of the injured vs. the non-injured part of brain. Under normal circumstances, the brain’s absorption should be symmetrical. When additional underlying extra vascular blood is present due to internal bleeding, there is a greater local concentration of hemoglobin and consequently the absorbance of the light is greater while the reflected component is commensurately less. This differential can be detected via sources and detectors placed on symmetrical lobes of the skull. The science of diffused optical tomography used by the Infrascanner™ enables the conversion of light differential data into interpretative scientific results. The Infrascanner™ unit is a small, portable handheld device based on a PDA platform with wireless detector probes.

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.

The device, called the Infrascanner Model 1000, can help health care providers identify patients with critical head injuries who need an immediate brain imaging study.

Intracranial hematomas occur when blood from a ruptured blood vessel collects within the brain or between the skull and the brain. As blood expands within the brain or in the narrow space between the brain and the skull, the brain becomes compressed. This can produce symptoms such as headaches, vomiting, dizziness, lethargy, weakness in the arm or leg on one side of the body, seizures, or unconsciousness. An intracranial hematoma can be life-threatening if it is not treated immediately.

The Infrascanner, Model 1000, uses a scanner that directs near-infrared light, a wavelength of light that can penetrate tissue and bone, into the skull. Blood from intracranial hematomas absorbs the light differently than other areas of the brain. The scanner detects differences in light absorption (optical density) and transmits the information wirelessly to a display on a hand-held computer.

By comparing the optical density from a series of scans of specific areas on both sides of the skull, a trained health care provider can use the information provided by the device, in conjunction with other clinical information, to determine the likelihood of an intracranial hematoma and the need for further diagnostic procedures, such as a computed tomography (CT) scan.

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.

The FDA is specifying special controls in an accompanying regulation classifying the Infrascanner Model 1000 as a Class II device with special controls. The special controls provide information about specific risks that must be addressed by other manufacturers who may wish to market a similar device. The Infra-scanner Model 1000 is manufactured by InfraScan Inc. of Philadelphia.

Source:http://medgadget.com/2011/12/infrascanner-looks-for-bleeding-in-brain-injury-victims.html, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm283520.htm

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  • http://www.injury-compensation-zone.co.uk/brain-injury-compensation/ Brain Injury Compensation

    Brain surgery is a procedure to treat problems in the brain and the surrounding structures. Before surgery, the hair on part of the scalp is removed and the area is cleaned. The doctor makes a surgical cut through the scalp and a hole in the skull is created. The doctor removes tumor from the brain. The hole area is covered with small metal plates or wires.

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