Regulatory Approvals

Paige,a global leader in clinical AI applications in pathology, announced it received CE-IVD and UKCA marks for the Paige Prostate Biomarker Suite, an AI...

MR 7700 imaging system features an enhanced gradient system for unmatched performance and precision, delivering Philips’ highest image quality to help improve diagnostic outcomesNewest...

CureApp, Inc. (Head Office: Chuo-ku, Tokyo; CEO: Kohta Satake) was notified by the Ministry of Health, Labour and Welfare on April 26, 2022 that...

ATUSA scans the entire breast volume automatically and provides 3D visualisation of the tissue in just two minutes. iSono Health has received approval from the...

Johnson & Johnson MedTech company Ethicon announced that its Monarch robotic surgery platform received FDA 510(k) clearance. Ethicon’s Auris Health subsidiary received the FDA clearance...

NANO-X IMAGING LTD ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, received...

Caretaker Medical announced that it received FDA 510(k) clearance for four new hemodynamic parameters for its VitalStream platform. Charlottesville, Virginia-based Caretaker’s wearable, wireless, non-invasive VitalStream platform...

GE Healthcare recently announced that it received FDA premarket approval for its End-tidal (Et) Control software for general anesthesia delivery. The software is approved for...

Aiforia Technologies Plc, Press Release, Aiforia Technologies Plc announces the CE-IVD marking of the Aiforia® Clinical AI Model for Breast Cancer; ER. Adding to...