Augmenix wins FDA nod for SpaceOar prostate treatment

Augmenix wins de novo clearance from the FDA for its SpaceOar hydrogel, which is designed to help protect surrounding tissue during prostate cancer radiation treatment.

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FDA clearance in hand, Augmenix is formulating U.S. commercial sales and insurance reimbursement plans for a medical gel designed to help protect the rectum during prostate cancer radiotherapy, CEP John Pedersen told MassDevice.com today.

Augmenix Inc., Food & Drug Administration (FDA)

News Well, De Novo Clearance, Prostate, Regulatory/Compliance, Urology

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