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FDA fast tracks Telix scan that could spare men prostate biopsies
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Fusion42 · 30 September 2026 · Fusion42 review
The FDA granted Fast Track designation to Telix Pharmaceuticals' BiPASS program, which aims to use a gallium-based PSMA PET scan alongside MRI to reduce unnecessary prostate biopsies. The designation could accelerate market approval and broaden patient access to this non-invasive diagnostic method.
This Wire brief sits within Fusion42's coverage of Medtech, and 2 sources have reported it between 30 Sep 2026 and 1 Oct 2026.
◆ ◆ The Wire takeaway
You can now position your prostate cancer diagnostic tech to compete for FDA fast-tracked approval if it reduces invasive biopsies. Telix’s success signals a new FDA openness to imaging alternatives shaping clinical decisions before biopsy.
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2 sources · first reported 30 Sep 2026 · latest 1 Oct 2026
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