Medical and Pharmaceutical Optellum breaks new ground with TGA approval for AI-powered lung nodule solution 'Radiological computer-assisted diagnostic software for lesions suspicious of cancer' is what the FDA calls it Rowan DunneMarch 5, 2026
Medical and Pharmaceutical Breath Diagnostics advances pre-op pneumonia screening with FDA breakthrough designation The FDA grants Breakthrough Device status to a limited group of technologies Joseph MortonFebruary 19, 2026
Medical and Pharmaceutical Guardant Health gets Breakthrough Device Designation from FDA for cancer detection test The FDA grants Breakthrough Device designation to devices that may offer more effective treatment or diagnosis of serious conditions like cancer Joseph MortonJune 24, 2025
AI and Autonomy Onc.AI’s lung cancer analysis tool gets FDA Breakthrough Device Designation It assesses mortality risk in non-small cell lung cancer patients Rowan DunneFebruary 11, 2025