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Medical Device Network1h
FDA grants breakthrough status to Roche’s VENTANA TROP2 device
The US FDA has granted breakthrough device designation to Roche's companion diagnostic VENTANA TROP2 (EPR20043) RxDx Device.
Medical Device Network18h
New data from J&J’s bladder cancer drug-device trial strengthens support for NDA
J&J submitted a New Drug Application to the FDA for TAR-200 in January 2025 following positive data from the SunRISe-1 trial.
Medical Device Network21h
Zenflow announces Spring System data for benign prostatic hyperplasia
Zenflow has reported that its Spring System demonstrated durable benefits three years post-placement for individuals with BPH ...