Boston Scientific Receives FDA clearance for SpaceOAR Flex Hydrogel

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  "signal_type": "news",
  "signal_subtype": "is_developing",
  "detected_at": "2026-09-29T13:37:01+00:00",
  "company": {
    "name": "Boston Scientific",
    "domain": "bostonscientific.com"
  },
  "data": {
    "url": "https://med-techinsights.com/2026/09/29/boston-scientific-receives-fda-clearance-for-spaceoar-flex-hydrogel/",
    "title": "Boston Scientific Receives FDA clearance for SpaceOAR Flex Hydrogel - med-techinsights.com",
    "excerpt": "Boston Scientific Corporation has received FDA 510(k) clearance for the SpaceOAR Flex Hydrogel, designed to temporarily create space between the prostate and rectum to reduce the radiation dose delivered to the rectum during prostate cancer radiation therapy. Prostate cancer is the second most common cancer diagnosis among men in the United States. Radiation therapy is a common treatment approach for prostate cancer, and rectal spacing is intended to minimise radiation exposure to the rectum during treatment. Building on the established SpaceOAR Hydrogel platform, SpaceOAR Flex is designed to help protect quality of life by minimising urinary, sexual and bowel side effects during prostate cancer radiation therapy. Boston Scientific says the hydrogel offers several features, including the ability to pause delivery, assess placement and adjust hydrogel delivery in real time; a single-syringe delivery system that enables physicians to place the entire hydrogel without changing syringes; and a simplified device set-up to reduce the number of steps when compared to SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel. “Rectal spacing has become an important tool for physicians seeking to limit radiation exposure to healthy tissue during prostate cancer treatment,” said Ronald Morton, M.D., Chief Medical Officer, Urology, Boston Scientific. “SpaceOAR Flex Hydrogel builds on our experience in...",
    "product": "SpaceOAR Flex",
    "summary": "Boston Scientific plans a limited market release of its SpaceOAR Flex Hydrogel in the United States later in 2026.",
    "location": "United States",
    "planning": true,
    "image_url": "https://med-techinsights.com/wp-content/uploads/2026/09/SpaceOAR-Hydrogel.png",
    "confidence": 0.9,
    "product_data": {
      "name": "SpaceOAR Flex",
      "full_text": "SpaceOAR Flex",
      "fuzzy_match": false
    },
    "product_tags": [
      "medical",
      "general_technology"
    ],
    "published_at": "2026-09-29T13:37:01Z",
    "location_data": [
      {
        "region": "Northern America",
        "country": "United States",
        "continent": "Americas",
        "fuzzy_match": false
      }
    ],
    "article_sentence": "Boston Scientific expects to begin a limited market release of SpaceOAR Flex in the United States later this year."
  }
}

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