Trade Resources Industry Views FDA Grants 510(K) Approval to Varian Brachytherapy Treatment Planning Solution

FDA Grants 510(K) Approval to Varian Brachytherapy Treatment Planning Solution

The US Food and Drug Administration (FDA) has granted 510(k) approval to Varian Medical Systems' Vitesse brachytherapy treatment planning solution.

The CE-marked solution enables clinicians to plan and perform high-dose-rate (HDR) brachytherapy treatments for prostate cancer using real-time ultrasound guidance.

The treatment involves delivery of radiotherapy from inside the body by temporarily placing a tiny radioactive source using a robotic device afterloader directly into the tumor or other targeted area.

The source is then moved within the needles under computer control to create the specified dose distribution within the patient's anatomy, claims the company.

Varian Medical Systems brachytherapy marketing manager Tim Clark said the new version of Vitesse also eliminates the need for a data transfer to another software program and avoids moving the patient to a CT scanner for images in the middle of the procedure.

"For these reasons, most clinicians will see a reduction in the amount of time needed to complete these treatments, often by as much as an hour and a half," Clark added.

Source: http://itsoftware.pharmaceutical-business-review.com/news/fda-approves-varian-brachytherapy-treatment-planning-solution-280113
Contribute Copyright Policy
FDA Approves Varian Brachytherapy Treatment Planning Solution