Updated AI and/or Machine Learning–Based Medical Devices Cleared Through the FDA 510(k) Pathway

• by Maria Zogka, Melissa Amyx, Philippe Ravaud, Viet-Thi Tran

• November 5, 2026

Critical appraisal of artificial intelligence studies for prostate cancer detection on MRI

• by Eduardo Pooch, Georgios Agrotis, Ivo G. Schoots, Mark Emberton, Veeru Kasivisvanathan, Yipeng Hu

• October 7, 2026

AI may predict focal GBM recurrence

Optical analysis of resection-margin tissue identified tumor infiltration as the strongest contributor to predictions of where glioblastoma later recurred.

• by Andrea Surnit

• October 15, 2026

• 4 min

STAT6 may aid diagnosis of giant pulmonary SFT

Immunohistochemical testing confirmed a rare tumor despite low-grade histology, extensive local involvement, and suspected liver metastasis.

• by Andrea Surnit

• October 22, 2026

• 4 min