SkinCure Oncology Submits GentleBeam Image-Guided SRT for FDA Clearance
SkinCure Oncology, a pioneer in providing comprehensive models for the delivery of Image-Guided Superficial Radiation Therapy (IGSRT) for nonmelanoma skin cancer, has announced the submission of its GentleBeam technology to the U.S. Food and Drug Administration for a 510(k) clearance. This innovative treatment option, widely presented as the GentleCure Experience to dermatology patients, reflects a significant leap forward in patient-centered care.
The GentleBeam technology is carefully designed to administer Image-Guided SRT, a modern noninvasive procedure that utilizes imaging techniques to precisely guide low-level x-rays to affected areas of the skin. This method represents an evolution in treatment strategies for skin cancers, allowing clinicians to provide effective care without the need for surgical interventions.
This recent submission is a vital milestone in SkinCure Oncology's commitment to promoting advanced technologies that prioritize patient needs and physician-led treatment practices. With the GentleBeam device, the company aims to deliver a compassionate and focused solution for treating nonmelanoma skin cancers, enhancing surgery-free options available to both patients and healthcare professionals.
Kerwin Brandt, the Chief Executive Officer of SkinCure Oncology, expressed enthusiasm regarding this advancement, stating, “We are excited to embark on this important process toward regulatory review of GentleBeam. Over the years, our more than 400 practice partners have effectively utilized GentleCure Image-Guided SRT, safely treating nearly 100,000 patients seeking less invasive alternatives. Our commitment to patients and their families is paramount, always focusing on what is best for them.” This statement emphasizes the company's unwavering dedication to leading innovative skin cancer treatment.
The FDA's 510(k) review process is established to determine if a new medical device is substantially equivalent to an already authorized device on the market. Once cleared, the GentleBeam technology will join SkinCure Oncology's existing solutions aimed at delivering tailored, impactful treatment options specialized for nonmelanoma skin cancer patients. Presently, it is important to note that GentleBeam has not yet received FDA clearance and is unavailable for commercial use at this time.
About SkinCure Oncology
SkinCure Oncology is a leader in offering a comprehensive model for Image-Guided Superficial Radiation Therapy (IGSRT), recognized as the most advanced nonsurgical option for treating common skin cancers. The company collaborates with quality-focused dermatologists, Mohs surgeons, and other medical professionals to provide radiation therapy that meets cancer center standards in private practice settings. Known as the GentleCure Experience, Image-Guided SRT is accessible through approximately 500 practitioners nationwide, with nearly 100,000 patients having benefited from this innovative treatment. To find out more about the company and their services, visit SkinCureOncology.com or explore GentleCure.com for useful consumer and patient resources.
Media Contact:
Matt Russell
Russell Public Communications
520-232-9840
Frequently Asked Questions
What is the GentleBeam technology?
GentleBeam technology is an Image-Guided Superficial Radiation Therapy designed to treat nonmelanoma skin cancer noninvasively, utilizing low-level x-rays for precision.
What does FDA clearance mean?
FDA clearance indicates that a medical device has been evaluated and found comparable to existing approved devices, allowing it to be marketed and used clinically.
Who can benefit from GentleBeam treatment?
GentleBeam treatment is suitable for patients with nonmelanoma skin cancers seeking noninvasive treatment options, particularly those interested in avoiding surgery.
How many patients have been treated with GentleCure technology?
Nearly 100,000 patients have been treated with SkinCure Oncology’s GentleCure Image-Guided SRT across the nation, showcasing its efficacy and safety.
Is GentleBeam available for use now?
No, GentleBeam is currently not FDA cleared, meaning it is not available for commercial distribution yet.
