Medical Devices
Gemcitabine-releasing bladder implant clears tumors in 82% of BCG‑unresponsive cases in phase 2 trial
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A catheter-delivered implant that slowly releases gemcitabine eliminated visible tumors in 82% of patients with BCG‑unresponsive, high‑risk non‑muscle‑invasive bladder cancer in a phase 2 study. More than half of responders remained cancer‑free for at least a year, and the device has since been approved by the FDA as Inlexzo for patients with carcinoma in situ who are ineligible for, or decline, bladder removal.
CNET has updated its recommendations for reliable at-home blood pressure monitors, all FDA-approved and endorsed by cardiologists. The list emphasizes accuracy, user-friendliness, and features like EKG integration for those tracking heart health. Monitoring is advised for everyone to establish baselines, especially for high-risk groups.
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Scientists have developed an ultra-sensitive Raman imaging system that identifies cancerous tissue by detecting faint light signals from nanoparticles bound to tumor markers. This technology, far more sensitive than current tools, could accelerate cancer screening and enable earlier detection. Led by researchers at Michigan State University, the system promises to bring advanced imaging into clinical practice.
The FDA granted several breakthrough device designations in September 2025 for innovative medical technologies. These designations expedite the development and review of devices addressing unmet needs. Updates include new approvals and predetermined change control plans.