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Xstrahl receives FDA 510(k) clearance for Radiant Aura treatment system

Radiant Aura is claimed to be the smallest office-based radiation therapy device currently available for dermatology practices.

RanjithKumar Dharma July 19 2023

Xstrahl has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Radiant Aura treatment system.

The new system has been developed to expand office-based treatment options for patients with non-melanoma skin cancer (NMSC).

Radiant Aura is claimed to be the smallest office-based radiation therapy device currently available for dermatology practices.

The company worked with clinical users to develop the treatment solution, which provides an extended range of motion and one-handed manipulation.

It also facilitates easy manoeuvrability because of its re-engineered treatment arm, including a new telescopic treatment head.

The patient set-up process is smooth, facilitated by a simple applicator and filter insertion and removal system. Its electromagnetic brakes help lock movements to improve patient safety.

Furthermore, the company is offering new 2.5cm, 5cm and 8cm applicators for more conformal radiation delivery.

Xstrahl CEO Adrian Treverton said: “We developed Radiant Aura to deliver both electronic brachytherapy and superficial radiation therapy in order to give dermatologists multiple treatment options for their NMSC patients.

“Low-dose, X-ray-based therapy gives dermatology practices a non-invasive treatment option for patients when surgery is not possible, contraindicated or simply not preferred due to cosmetic concerns.

“Radiant Aura is the new generation of Radiant systems and has had multiple upgrades based on our early users’ experience and recommendations.”

Xstrahl is engaged in the design of radiation delivery devices for cancer researchers and clinical teams.

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