WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA makes the Boston Scientific Imager II removal a Class I recall Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical Microbot Medical puts Liberty in 12 sales territories and targets positive gross margin in 2027 NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 FDA drafts surgical robot testing expectations and leaves autonomy out of scope Marani Health clears the M•care system for fetal and maternal monitoring at home FDA books December 2 and 3 for a workshop on robot autonomy and remote teleoperation Biolinq clears Shine for over-the-counter sale a year after its De Novo FDA makes the Boston Scientific Imager II removal a Class I recall Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical Microbot Medical puts Liberty in 12 sales territories and targets positive gross margin in 2027 NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 FDA drafts surgical robot testing expectations and leaves autonomy out of scope Marani Health clears the M•care system for fetal and maternal monitoring at home FDA books December 2 and 3 for a workshop on robot autonomy and remote teleoperation Biolinq clears Shine for over-the-counter sale a year after its De Novo

510(k)

Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection

MedDevice Startups Staff · 3 days ago · 2 min read · Via Urology Times

Boston Scientific announced FDA 510(k) clearance of SpaceOAR Flex Hydrogel on September 25 under K262151. The device places a temporary gel spacer between the prostate and the anterior rectal wall, so radiation aimed at the prostate misses rectal tissue.

The change from SpaceOAR Vue is procedural. Flex ships in a single syringe. The physician can pause partway through the injection, look at how the gel has spread, and adjust before continuing. Setup takes fewer steps than earlier models. The gel stays visible on CT, including kV cone beam CT, so it shows up on the image guidance already running in the treatment room.

This reads as a human factors clearance more than a materials one. The hydrogel chemistry is not the news. The ability to stop and correct a misplacement is. Anyone writing a 510(k) around a delivery change should expect the reviewer's questions to land on use-related risk analysis rather than biocompatibility. Limited US release comes later in 2026.

Questions & Answers

What is Boston Scientific SpaceOAR Flex Hydrogel?

SpaceOAR Flex Hydrogel is a Boston Scientific rectal spacer cleared by FDA on a 510(k) under K262151. It holds the anterior rectal wall away from the prostate during radiation therapy for prostate cancer.

How is SpaceOAR Flex different from SpaceOAR Vue?

SpaceOAR Flex uses a single syringe and lets the physician pause during injection to evaluate placement and adjust before continuing. Boston Scientific says its CT visibility is comparable to SpaceOAR Vue.

When will SpaceOAR Flex be available in the United States?

Boston Scientific expects a limited US market release of SpaceOAR Flex later in 2026. SpaceOAR and SpaceOAR Vue stay on the market.

← Back to Newly Cleared