FDA clears SpaceOAR Flex hydrogel spacer for prostate radiotherapy

FDA 510(k) · Urology Times · 2026-09-25. Number 2 in the UrologyWatch Top 5 for September 26, 2026.

510(k) clearance for a next-generation rectal spacer; limited US market release is planned later in 2026.

Why it matters: Relevant to programs offering spacer placement with SBRT or hypofractionated radiation.

Source: Urology Times

The full September 26, 2026 edition · Today's urology news

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