" class="no-js "lang="en-US"> Pink Luminous Breast (PLB) Takes Steps Toward FDA Class III Approval - Medtech Alert
Friday, April 12, 2024

Pink Luminous Breast (PLB) Takes Steps Toward FDA Class III Approval

Pink Luminous Breast (PLB) is continuing to make strides in breast cancer awareness with a new clinical study released exploring the potential recommendation of the device to be used for routine breast screenings in non-clinical settings. The PLB device is not intended to replace the annual mammogram but does provide a form of screening in-between exams, and for women under the age of 40, who do not qualify for a mammogram yet based on the estimated risk score. Because breast cancer is the leading cause of female specific cancer death in the United States, detection at earlier stages contributes to decreasing the mortality rate. The study validates the use of the PLB device as a complement tool, providing more efficient earlier detection strategies. Funding for this study was provided through donations to the Pink Luminous Advocacy Project, and SilkProUSA, the mother brand of Pink Luminous Breast.

The PLB works by emitting a RED LED light with a harmless spectrum of 640-800 nanometers, the trans-illuminated breast tissue allows the observation of abnormalities represented by darker or shadow areas. This double blinded study evaluated the sensitivity and specificity of the PLB device as a screening tool for the early detection of breast abnormalities when compared with mammography as the gold standard. The results showed that the PLB device has a high sensitivity (89.6%) and specificity (96.4%) for detecting breast abnormalities comparable to the adjusted mammography variables: 86.3% and 68.9% respectively. Importantly, the percentage of positive dense tissue findings from a total of 340 events was 266 (78.2%) using PLB vs. 248 (72.9%) detected by the mammography (MedRxiv, 2021).

“The results obtained using the PLB revolutionize the early detection of potential cancer lesions, positively changing the outcomes of cancer survival at any population,” said Dr. Edu B. Suarez, author of the study.

The PLB is an innovative, safe, and effective way for women to better understand their breast health in the comfort of their homes. It is a one-of-a-kind device that helps increase awareness, as a preliminary screening tool to assist women in their regular breast care routine anywhere due to its portability. The objective is to educate women across the country and abroad about being proactive with breast health familiarity. It gives women an opportunity to monitor visual changes in their breasts through transillumination.

“Our goal, since inception, has been to create awareness and make self-familiarity a part of a woman’s daily routine,” said Marylin Dans, founder, and CEO of Pink Luminous Breast. “Pink Luminous Breast is more than a device; it is a lifestyle. Thanks to the generosity of donors to the Pink Luminous Advocacy Project we are able to continue on the path of FDA Class III approval and becoming an industry gold standard.”

The Pink Luminous Advocacy Project is a 501(c)3 organization that aims for the education of women and men on the need to be proactive with their breast health, by disseminating awareness, prevention, and detection strategies at early stages. The organization is focused on investing in research, specifically as it relates to how red LED spectrum light can be used to detect early breast changes that may lead to the development of breast cancer. The clinical study is part of a mission that continues on as the company seeks FDA Class III approval. Additionally, the organization launched the Breast Awareness App in 2019, in an effort to make regular breast cancer screenings simple and convenient for both women and men. The app walks the user through the proper steps of an at-home breast examination and allows users to gain familiarity with their body and learn to detect possible abnormalities that require immediate action.

Following the success of the initial clinical study, the PLB moves on to seek Class III approval by the FDA. In order to do so, the organization is seeking support from the community to be able to raise funds for additional research and development resources that will put the PLB in the hands of more women around the world. This is a historical event, giving women everywhere the power to have an at-home breast screening tool for the first time ever, and allowing them to live an awareness lifestyle. The company counts on the support of a diversity of ambassadors, and stakeholders, including Tony Figueroa Cisneros and family, a select group of doctors such as Dr. Moises Irizarry– Roman, and the pop star, entrepreneur and education advocate, Armando Christian Perez (Pitbull).

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