The EmeraldLED, a novel medical device proposed for body composition improvement, has entered a new phase of clinical research. This announcement highlights ongoing clinical trials aimed at evaluating the device’s potential, backed by Efforia, Inc.
What changed?
Efforia, Inc, the sponsor of the EmeraldLED clinical research, is currently recruiting participants for a new trial. The study is hosted on ClinicalTrials.gov under the condition category of body composition as of December 15, 2025. Clinical and regulatory professionals may find the study’s recruitment phase relevant for understanding shifts in device-based interventions.
Device and study overview
The EmeraldLED device utilizes green light technologies to potentially influence body composition metrics. While specific study results are not yet available, the trial symbolizes a proactive step toward assessing innovative medical technologies under controlled clinical settings.
Body composition studies explore the proportion of fat, muscle, water, and bone in the human body. By targeting this condition, EmeraldLED could provide a non-invasive route to assist in body parameter optimization. Regulated trials such as this are instrumental for generating reliable safety and performance data required under medical device regulations worldwide.
Why focus on non-invasive solutions?
Minimizing invasive procedures aligns with patient safety priorities. EmeraldLED seeks to offer therapeutic benefits without surgical risks, providing an attractive option for both clinicians and patients, assuming clinical evidence substantiates its effectiveness.
Potential implications for healthcare
Should the study establish positive outcomes, professionals in clinical and regulatory fields may observe increased interest in device-driven therapies. This highlights an ongoing trend in favor of precision-guided, non-invasive therapeutic solutions.
Manufacturer and support
Efforia, Inc, credited as the sponsor, leads the EmeraldLED study. Sponsors play a pivotal role in funding, designing, and monitoring the compliance of device-based trials. Their involvement ensures that research aligns with both regulatory standards and scientific integrity.
Professionals tracking device certifications or pre-market requirements may wish to follow this investigation. Continued enrollment and testing will determine whether the intervention fulfills MDR Annex XIV expectations.
FAQs
- What is the EmeraldLED device?
It is a green-light-based medical device currently under investigation for improving body composition. - Who is conducting the clinical trial?
Efforia, Inc sponsors the research, listed as active and recruiting participants. - Where can I find more details on the trial?
Visit the ClinicalTrials.gov listing here. - What are the intended benefits of the device?
The intervention aims to assist with body composition optimization using non-invasive methods, pending clinical validation. - What regulatory significance does this trial hold?
The study serves as a step to establish evidence of safety and performance for possible market authorization.
Conclusion
The active recruitment phase marks an important juncture in EmeraldLED’s advancement. With meaningful safety and performance data, the device could gain recognition as a viable non-invasive solution for body composition support. Clinical and regulatory teams should monitor results for updates on the device’s potential clearance and patient impact.
Disclaimer
This content provides an informational overview for professionals. It is not intended as legal or regulatory advice. Always consult applicable laws and standards in your jurisdiction.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07282080?term=medical+device