January 26, 2018 – After extensive review and evaluation, the U.S. Food and Drug Administration (FDA) recently cleared Multi Radiance Medical’s MR4 Laser technology for neck and shoulder pain relief under the Product Classification NHN, making Multi Radiance one of the few therapeutic laser manufacturers in the world that have secured the NHN product class FDA 510(k) clearance.
While many therapeutic laser companies sell products in the United States, only a limited number have received clearance under the NHN designation, indicating a non-thermal device.
“The reason for this,” states Multi Radiance president and CEO, Max Kanarsky, “is the very rigorous and expensive process, which includes conducting and submitting data to support the claims of safety and effectiveness.”
The results of the randomized, double blind, controlled study submitted show that Multi Radiance MR4 Laser technology is more effective than placebo for reducing neck and shoulder pain.
Statistics reveal that around 35 million adults in the U.S. suffer from neck pain1, and neck pain is second only to low back pain in annual workers’ compensation costs in the United States2. The new NHN classification gives clinicians and patients a clinically proven safe and effective alternative to opioids and other drugs for managing this common pain.
This is the latest visible step in Multi Radiance’s quest to become the dominant market leader in laser therapy.
“Globally, Multi Radiance Medical participates currently in over 30 clinical trials and publishes more than 10 peer reviewed articles each year,” added Douglas Johnson, senior VP, clinical and scientific affairs. “We want to congratulate our regulatory team, Dr. Ernesto Leal Junior, and our research team at the Laboratory of Phototherapy in Sports and Exercise on this remarkable achievement”.
Source: Multi Radiance Medical
References
- Center for Disease Control and Prevention (CDC). (2015). Severe headache or migraine, low back pain, and neck pain among adults aged 18 and over, by selected characteristics: United States, selected years 1997–2014. Retrieved from https://www.cdc.gov/nchs/data/hus/2015/041.pdf
- Wright, A., Mayer, T. G., & Gatchel, R. J. (1999). Outcomes of disabling cervical spine disorders in compensation injuries: a prospective comparison to tertiary rehabilitation response for chronic lumbar spinal disorders. Spine, 24(2), 178-183.
