Multi Radiance Medical Receives FDA Clearance for Lateral Epicondylitis Treatment
Multi Radiance Medical Expands FDA-Cleared Indications with New Lateral Epicondylitis Clearance Following Successful Triple-Blind Clinical Trial
Businesswire
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Multi Radiance Medical has secured FDA clearance for the MR5 ACTIV PRO Super Pulsed Laser to treat lateral epicondylitis, a common cause of elbow pain. This clearance follows a successful clinical trial showing a 72% success rate in pain relief, enhancing non-invasive treatment options for musculoskeletal pain.
- 01The MR5 ACTIV PRO laser is now FDA-cleared for treating lateral epicondylitis, adding to its existing clearances for fibromyalgia and neck and shoulder pain.
- 02The clinical trial demonstrated a 72% success rate in pain relief compared to 40% for placebo (p=0.045).
- 03The study results were published in BMJ Open, providing significant clinical evidence for the treatment's effectiveness.
- 04Multi Radiance Medical emphasizes the importance of scientific validation in developing their technologies.
- 05The MR5 ACTIV PRO combines multiple wavelengths of light for effective pain relief.
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Multi Radiance Medical (MRM) has announced that the U.S. Food and Drug Administration (FDA) has granted NHN 510(k) clearance for the MR5 ACTIV PRO Super Pulsed Laser, specifically for the temporary relief of pain associated with lateral epicondylitis, commonly known as tennis elbow. This condition affects approximately 10.5 million adults globally each year, primarily impacting those engaged in repetitive activities that stress the elbow. A recent triple-blind, placebo-controlled clinical trial demonstrated that 72% of participants receiving the active treatment achieved clinical success, compared to 40% in the placebo group (p=0.045). The findings, published in BMJ Open, reinforce MRM's commitment to evidence-based, non-invasive treatment options for musculoskeletal pain. This new indication complements existing FDA clearances for treating fibromyalgia and neck and shoulder pain, expanding the clinical applications of MRM's technology. MRM's leadership emphasized the importance of scientific rigor in validating their treatments, ensuring healthcare professionals can confidently provide effective, drug-free options for patients suffering from pain.
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This FDA clearance provides healthcare professionals with a validated, non-invasive treatment option for patients suffering from lateral epicondylitis, potentially improving patient care and outcomes.
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