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Nucletron obtains FDA 510(k) approval for Esteya electronic brachytherapy system

Nucletron, an Elekta Company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for Esteya electronic brachytherapy system, a new approach for high precision skin cancer treatment.

Depending on a small, high dose rate, the system applies therapeutic radiation directly to the cancerous site, while reducing the radiation to surrounding tissues and organs.

The electronic brachytherapy technique achieves greater than 95% cure rate in treating skin lesions, such as basal cell or squamous cell carcinoma.

Elekta Brachytherapy executive vice president John Lapre noted the interest in Esteya among radiation oncologists during the American Society for Radiation Oncology annual meeting last week in Atlanta was encouraging.

"They appreciated the efficient workflow, easy patient set-up, and the short treatment delivery time," Lapre added.

"They also cited the accessibility of Esteya – due to its compact design and reduced shielding requirements – allowing treatment to occur virtually anywhere patients are seen within the clinic."

Esteya systems are expected to be installed in the US in the next few months and the systems availability in the target markets will be based on regulatory admissions and approvals.