In the phase 3 PANOVA-3 trial, adding Tumor Treating Fields therapy to gemcitabine and nab-paclitaxel was associated with improved overall survival and delayed pain progression in adults with locally advanced pancreatic cancer.
“These findings indicate that standardized efficacy, safety, and risk assessment reporting remains inadequate for FDA-cleared AI/ML devices, underscoring the need for dedicated regulatory pathways and robust postmarket surveillance to ensure patient safety."