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.
According to the Centers for Disease Control and
Prevention, each year about 1.7 million people in the United States
experience a traumatic brain injury.
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.
“While
patients with suspected brain injuries routinely receive a CT scan, this
portable device offers emergency room physicians a non-invasive
mechanism to aid in assessing whether an immediate CT scan is needed,”
said Christy Foreman, director of the Office of Device Evaluation at
FDA’s Center for Devices and Radiological Health.
The FDA reviewed
data for the Infrascanner Model 1000 through the “de novo”
classification process, a regulatory pathway for some low to moderate
risk medical devices that are not comparable to a legally marketed
device.
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 Infrascanner Model 1000 is manufactured by InfraScan Inc. of Philadelphia.
For more information:
The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.
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