Medical Policy

This document addresses the use of near-infrared spectroscopy (NIRS) for the screening and detection of brain hematomas and intracranial bleeding. The InfraScanner^® (InfraScan, Inc., Philadelphia, PA) handheld brain scanner unit uses NIRS for the detection of possible development of intracranial hematomas in high-risk individuals, such as those with head trauma.

Investigational and Not Medically Necessary:

Near-infrared spectroscopy scanning for brain hematoma screening (that is, InfraScanner) is considered investigational and not medically necessary for all indications.

Summary

InfraScanner is an FDA-cleared handheld device that uses near-infrared light to detect brain bleeding after head trauma, specifically for blood clots larger than 3.5 mL within 2.5 cm of the skull surface. The device works by comparing light absorption between the left and right sides of the head. Initial studies showed 69% sensitivity and 91% specificity overall, improving to 88% sensitivity for bleeds within its detection range. However, subsequent real-world evidence has been inconsistent. A pooled analysis found 78% sensitivity and 90% specificity, but field studies revealed practical challenges including incomplete scans and false positives from scalp bleeding. Other studies continue to show variable performance: one emergency department study found only 60% sensitivity with 25% positive predictive value, while a machine-learning version claimed 96% sensitivity without independent validation. The device tends to not detect smaller hemorrhages and has limited utility for tracking bleeding over time. There are no current medical society guidelines that address the use of near-infrared detection for evaluating bleeding in the brain. The current standard of care for such conditions is the use of CT scans.

Discussion

A near-infrared brain hematoma detector, InfraScanner 2000, received U.S. Food and Drug Administration (FDA) 510(k) clearance in January 2013 for adjunctive detection of traumatic supratentorial hematomas larger than 3.5 mL and within 2.5 cm of the brain surface; indications for Model 2500 are identical (FDA 510(k) summary). On December 12, 2024, the FDA cleared an updated InfraScanner Model 2500 (K241389). The update increased laser power from 100 mW to 200 mW to improve measurements in individuals with very dark skin. Bench testing showed similar performance at both power settings, and the clinical dataset documented three  individuals with very dark skin who could not be measured at 100 mW but were successfully measured at 200 mW. The labeling is unchanged; the device may help identify individuals who likely have a traumatic supratentorial hematoma and should proceed to computed tomography (CT), but it cannot be used to rule out a hematoma or replace CT (FDA 2024).

Near-infrared (NIR) light penetrates hair, scalp, skull, dura, and superficial brain. By exploiting hemoglobin absorbance and side-to-side comparisons, unilateral hemorrhage can be inferred. Early NIRS studies were encouraging but small (Francis, 2005; Kahraman, 2007; Kessel, 2007). In a multicenter cohort, overall sensitivity was 68.7% and specificity 90.7%, improving to 88.0% and 90.7% for lesions within the device’s detection window (Robertson, 2010). Pediatric data were exploratory and called for multicenter validation (Bressan, 2014).

Post-2015 evidence remains mixed. A meta-analysis reported pooled sensitivity 78% and specificity 90% across heterogeneous devices and settings (Brogan, 2017). Field and transport studies showed feasibility but variable accuracy: sensitivity 93.3% and specificity 78.6% with frequent incomplete scans in aeromedical use (Peters, 2017); sensitivity 95.6% and specificity 92.5% in a single-center series with methodological caveats (Xu, 2017); frequent false positives in healthy volunteers (Schober, 2017). In a military hospital cohort limited to hematomas within the detection range, sensitivity was 100% and specificity 93.6%, but exclusions and false positives from subgaleal hematomas were notable (Liang, 2018). An emergency-department series reported sensitivity 75% and specificity 50.43%, cautioning against decision-making based on NIRS alone (Kontojannis, 2019). A systematic review spanning 19 studies found sensitivity ranging from 57.1-100% and specificity 29-100%, with similarly wide positive predictive value (PPV) and negative predictive value (NPV) ranges, underscoring inconsistency and the need for more robust studies (Videman, 2022).

More recent studies refine, but do not resolve these uncertainties. In a prospective cohort of 140 adults with blunt traumatic brain injury (TBI) evaluated within 6 hours, InfraScanner 2000 showed sensitivity 60.0%, specificity 78.4%, PPV 25.0%, and NPV 94.2%, suggesting potential utility to rule out ICH when CT access is constrained but limited ability to confirm ICH (Cardona-Collazos, 2025). A study involving the use of a non-FDA cleared machine-learning NIRS system (CEREBO^®) in 240 CT-referred individualsreported sensitivity 96%, specificity 97%, accuracy 97%, Youden’s index 0.93, likelihood ratio positive 29.13, and likelihood ratio negative 0.04 across 1,288 lobes, with performance consistent across age groups (Shah, 2024). These effect sizes are compelling but derive from a single center using proprietary indices; independent replication and head-to-head comparisons with InfraScanner are needed. In a study evaluating the use of the InfraScanner in  378 individuals undergoing emergency-department triage for headache, a right-left cerebral oxygenation difference (ΔrSO₂) ≥9 yielded 100% specificity and 100% PPV for ICH within that sample, while absolute rSO₂ values were lower in ICH than comparators (Çınaroğlu, 2024). This physiologic threshold is hypothesis-generating and requires external validation with prospective sensitivity and calibration reporting. Finally, in a prospective feasibility study of serial monitoring among 62 individualswith CT-confirmed ICH, hourly scans were completed in 88% of 340 opportunities, but expansion detection could not be demonstrated; median baseline hematoma volume was 2.5 mL, often below the device’s detection threshold, and missed scans were frequently due to technical or access barriers (Jansen, 2025). These operational details explain real-world constraints on performance.

Major U.S. guidelines do not endorse near‑infrared spectroscopy for screening or diagnosing intracranial hemorrhage after head trauma. The VA/DoD concussion and mild TBI guideline (2021) assigns no role to NIRS in the acute evaluation and centers imaging on CT when indicated.  The American College of Radiology (ACR) appropriateness criteria for head trauma designate noncontrast head CT as usually appropriate for moderate to severe injury and for mild injury when a validated decision rule indicates imaging, and they do not include NIRS among recommended modalities (Shih, 2021).  The 2024 American College of Emergency Physicians (ACEP) clinical policy on acute blunt trauma frames initial imaging around CT, using clinical judgment in hemodynamically stable individuals, with no recommendation for NIRS (2024).  The Brain Trauma Foundation (BTF) severe TBI guideline emphasizes CT‑based diagnosis and physiologic monitoring domains and does not include NIRS within recommended monitoring or thresholds (Carney, 2017).  These concordant positions support maintaining NIRS as investigational and, at most, an adjunct where CT access is constrained, without altering CT‑based triage or management pathways.

According to the Centers for Disease Control and Prevention (CDC), in 2021 there were over 69,000 TBI-related deaths in the United States. According to the CDC, a TBI “is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the normal function of the brain." These injuries are principally the result of motor vehicle accidents, violence, sports injuries, and falls. Individuals who have suffered a TBI often experience residual impairments affecting motor control, communication skills, social behavior and cognition. These deficits may result in a variety of alterations in the individual, including but not limited to changes in memory, language, attention and concentration, visual processing, reasoning, and problem-solving, as well as emotional and behavioral control.

The InfraScanner brain imaging system is a portable device created to detect and evaluate traumatic supratentorial hematomas. The technology compares regional differences in absorbance of NIR light. The application of NIRS to hematoma evaluation is based on the principle that intracranial hemoglobin concentration will differ where a hematoma is present, compared to hemoglobin concentrations in normal intracranial regions.

Hematoma: Localized swelling filled with blood, resulting from a ruptured blood vessel.

Traumatic brain injury (TBI): Occurs when an external mechanical force causes brain dysfunction, often associated with a diminished or altered state of consciousness, and potentially leads to permanent or temporary impairment of cognitive, physical, and psychosocial functions. TBI usually results from a violent blow or jolt to the head or body, but can also be caused by an object penetrating the skull.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Bressan S, Daverio M, Martinolli F, et al. The use of handheld near-infrared device (InfraScanner) for detecting intracranial haemorrhages in children with minor head injury. Childs Nerv Syst. 2014; 30(3):477-484.
2. Brogan RJ, Kontojannis V, Garara B, et al. Near-infrared spectroscopy (NIRS) to detect traumatic intracranial haematoma: a systematic review and meta-analysis. Brain Inj. 2017; 31(5):581-588.
3. Cardona-Collazos S, Olaya-Perea S, Fernández L, Griswold D, et al. Performance of the InfraScanner for the detection of intracranial bleeding in a population of traumatic brain injury patients in Colombia. Emerg Care Med. 2025; 2(3):35.
4. Çınaroğlu OS, Bora ES, Acar H, et al. Is near-infrared spectroscopy a promising predictor for early intracranial hemorrhage diagnosis in the Emergency Department? Braz J Med Biol Res. 2024; 57:e13155.
5. Fox WC, Park MS, Belverud S, et al. Contemporary imaging of mild TBI: the journey toward diffusion tensor imaging to assess neuronal damage. Neurol Res. 2013; 35(3):223-232.
6. Francis SV, Ravindran G, Visvanathan K, Ganapathy K. Screening for unilateral intracranial abnormalities using near infrared spectroscopy: a preliminary report. J Clin Neurosci. 2005; 12(3):291-295.
7. Jansen JO, Liptrap E, Black J, et al. Noninvasive monitoring of traumatic intracranial hematoma progression using the infrascanner: preliminary experience. J Am Coll Emerg Physicians Open. 2025; 6(2):100091.
8. Kahraman S, Kayali H, Atabey C, et al. The accuracy of near-infrared spectroscopy in detection of subdural and epidural hematomas. J Trauma. 2006; 61(6):1480-1483.
9. Kessel B, Jeroukhimov I, Ashkenazi I, et al. Early detection of life-threatening intracranial haemorrhage using a portable near-infrared spectroscopy device. Injury. 2007; 38(9):1065-1068.
10. Kontojannis V, Hostettler I, Brogan RJ, et al. Detection of intracranial hematomas in the emergency department using near infrared spectroscopy. Brain Inj. 2019; 33(7):875-883.
11. Leon-Carrion J, Dominguez-Rolan JM, Leon-Dominguez U, Murillo-Cabezas, M. The InfraScanner, a hand held device for screening in situ for the presence of brain haematomas. Brain Inj. 2010; 24(10)10:1193-1201.
12. Liang CY, Yang Y, Shen CS, et al. Chinese military evaluation of a portable near-infrared detector of traumatic intracranial hematomas. Mil Med. 2018; 183(7-8):e318-e323.
13. Peters J, Van Wageningen B, Hoogerwerf N, Tan E. Near-infrared spectroscopy: a promising prehospital tool for management of traumatic brain injury. Prehosp Disaster Med. 2017; 32(4):414-418.
14. Robertson CS, Zager EL, Narayan RK, et al. Clinical evaluation of a portable near-infrared device for detection of traumatic intracranial hematomas. J Neurotrauma. 2010; 27(9):1597-1604.
15. Schober P, Bossers SM, Schwarte LA. Intracranial hematoma detection by near infrared spectroscopy in a helicopter emergency medical service: practical experience. Biomed Res Int. 2017; 2017:1846830.
16. Shah J, Solanki S, Chandra A, et al. Evaluating performance of a near-infrared-spectroscopy-based and machine-learning-powered bio-optical sensitivity parameters in identifying intracranial hemorrhages in TBI across different age-groups. Brain Inj. 2024; 38(14):1227-1235.
17. Viderman D, Ayapbergenov A, Abilman N, Abdildin YG. Near-infrared spectroscopy for intracranial hemorrhage detection in traumatic brain injury patients: a systematic review. Am J Emerg Med. 2021; 50:758-764.
18. Xu L, Tao X, Liu W, et al. Portable near-infrared rapid detection of intracranial hemorrhage in Chinese population. J Clin Neurosci. 2017; 40:136-146.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American College of Emergency Physicians Clinical Policies Subcommittee (Writing Committee) on Blunt Trauma, Gerardo CJ, Blanda M, et al. Clinical policy: critical issues in the evaluation of adult patients presenting to the emergency department with acute blunt trauma. Ann Emerg Med. 2024; 84(4):e25-e55.
2. Carney N, Totten AM, O'Reilly C, et al. Guidelines for the management of severe traumatic brain injury, fourth edition. Neurosurgery. 2017; 80(1):6-15.
3. Department of Veteran Affairs Department of Defense. VA/DoD clinical practice guideline for management of concussion/mild traumatic brain injury. Washington (DC): Department of Veteran Affairs, Department of Defense; 2021. Available at: https://www.healthquality.va.gov/guidelines/Rehab/mtbi/VADoDmTBICPGFinal508.pdf. Accessed on September 2, 2025.
4. Giza CC, Kutcher JS, Ashwal S, et al. Summary of evidence-based update: evaluation and management of concussion in sports: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2013; 80(24):2250-2257.
5. Shih RY, Burns J, et al. ACR appropriateness criteria head trauma: 2021 update. J Am Coll Radiol. 2021; 18(5S):S13-S36.
6. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. InfraScan, Inc. InfraScanner Model 2000. Rockville, MD: FDA. January 11, 2013. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf12/k120949.pdf. Accessed on September 2, 2025.
7. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. InfraScan, Inc. InfraScanner Model 2500. Rockville, MD: FDA. July 10, 2020. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200203.pdf. Accessed on September 2, 2025.
8. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. Infrascan, Inc. Infrascanner Model 2500. Silver Spring, MD: FDA. December 12, 2024. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241389.pdf. Accessed on September 2, 2025.

1. Centers for Disease Control and Prevention. Facts about TBI. August 4, 2025. Available at: https://www.cdc.gov/traumatic-brain-injury/data-research/facts-stats/?CDC_AAref_Val=https://www.cdc.gov/traumaticbraininjury/get_the_facts.html. Accessed on September 2, 2025.
2. National Institute of Neurological Disorders and Stroke (NINDS). July 21, 2025. Traumatic brain injury (TBI). Available at: https://www.ninds.nih.gov/Disorders/All-Disorders/Traumatic-Brain-Injury-Information-Page. Accessed on September 2, 2025.

InfraScanner 2000
InfraScanner 2500
Near-Infrared Spectroscopy
Traumatic Brain Injury

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