Navigation Links
FDA Permits Marketing of the First Hand-Held Device To Aid in the Detection of Bleeding In The Skull
Date:12/13/2011

SILVER SPRING, Md., Dec. 13, 2011 /PRNewswire-USNewswire/ -- 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.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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:

FDA: Medical Devices
http://www.fda.gov/MedicalDevices/default.htm

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.

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov  
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Permits Marketing of First Test to Help Diagnose Dengue Fever
2. Vantage Health Announces That All of Its Required Tanzanian Registrations, Permits and Licenses Have Been Formally Issued, Simultaneous With Official Notification That Its Application for Phase One Evaluation of Its HIV Screening Test Kits Has Been
3. FDA Permits Marketing of a System to Repair Failed, Problematic Fix for Aortic Aneurysms
4. FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol(R)
5. ADVENTRX Announces Completion of Patient Enrollment in ANX-530 Marketing-Enabling Clinical Study
6. ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study
7. Pharmion Submits European Marketing Authorization Application (MAA) for Vidaza(R) in Patients with Higher-Risk Myelodysplastic Syndromes (MDS)
8. Infant Formula Manufacturers Again under Ethical Cloud: Marketing Gimmick Linked to Serious Illnesses
9. Cell Therapeutics, Inc. (CTI) Submits European Marketing Authorization Application for XYOTAX(TM)
10. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
11. AMT Prepares for Submission of Marketing Authorization Dossier for AMT-011 (Glybera(R))
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/28/2017)... This morning,s research on ... The Medicines Co. (NASDAQ: MDCO), Ironwood Pharmaceuticals Inc. ... Supernus Pharmaceuticals Inc. (NASDAQ: SUPN ). ... which is governed by the same governing framework ... industry are wholesalers, retailers, pharmacies, and benefit managers. Learn ...
(Date:3/28/2017)... , March 28, 2017  AcelRx Pharmaceuticals, ... on the development and commercialization of innovative therapies ... that the European Medicines Agency (EMA) has notified ... 30 mcg) Marketing Authorisation Application (MAA) has passed ... MAA is underway. The MAA for ARX-04 (known ...
(Date:3/28/2017)... FRANCISCO , March 28, 2017 ...  is expected to reach a value of USD 4.5 ... Grand View Research, Inc. Proper closure of injured tissues ... structure and function. Postoperative leakages occur in 3% to ... complication. They are responsible for one third of postoperative ...
Breaking Medicine Technology:
(Date:3/28/2017)... ... March 28, 2017 , ... ... Paul Yost, will begin serving as new board chair for Orange County health ... will serve the remainder of soon-to-be former chair Mark Refowitz’s term, which runs ...
(Date:3/28/2017)... Francisco, CA (PRWEB) , ... March 28, 2017 , ... ... people suffering from acne, access to quality care can be limited while the desire ... company that offers customized prescription acne care for every customer online, today released its ...
(Date:3/28/2017)... ... March 28, 2017 , ... The Executives, Staff & Clients ... to for the Toys for Tots Literacy Campaign at their Semi-Annual Graduation and Fundraiser ... $70 billion, the U.S. ranks at number 14 internationally in literacy. Statistically, a direct ...
(Date:3/28/2017)... ... March 28, 2017 , ... ... offered by the American Association of Integrative Medicine and available for application on ... at the AutismOne 2017 Conference in Colorado Springs. , Ed Arranga, president of ...
(Date:3/28/2017)... , ... March 28, 2017 , ... ... Tri-State Camp Conference in Atlantic City March 13-16, was a busy spot this ... of professional staff discussed strategies for preventing outbreaks among camp communities during the ...
Breaking Medicine News(10 mins):