25/08/2025 Quest Diagnostics' Haystack MRD® test received the Breakthrough Device Designation from the FDA for colorectal cancer (Ref) The US FDA granted the Breakthrough Device Designation for Quest Diagnostics' Haystack MRD® test for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling. Dan Edelstein, Vice President and General Mana

09/07/2025 Artera's ArteraAI Prostate received the Breakthrough Device designation from the US FDA (Ref) The US FDA granted the Breakthrough Device designation to Artera's ArteraAI Prostate (an AI precision medicine tool) intended to assist clinicians with risk-based decisions for patients with localized prostate cancer ArteraAI Prostate analyzes digital pathology images of the prostate cancer biopsy slide to prognosticate long-term outcomes, such as 10-yr risk of distant met