June 05, 2025 — Nano-X Imaging Ltd. has announced that its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd, has received EU MDR CE (Conformité Européenne) mark certification for HealthOST, an SaMD (Software as a medical device) for bone health analysis, enabling its commercialization across Europe and ensuring compliance with the highest regulatory standards for medical software.

June 2, 2025 — Clairity, Inc., a digital health innovator advancing AI-driven healthcare solutions, has received U.S. Food and Drug Administration (FDA) De Novo authorization for Clairity Breast, a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram. With this authorization, Clairity is planning to launch among leading health systems through 2025 – propelling a new era of precision medicine in breast cancer.

May 29, 2025 — Hyperfine, Inc., producer of the world’s first FDA-cleared AI-powered portable MRI system for the brain — the Swoop system — has announced FDA clearance of its next-generation software.

May 20, 2025 — Royal Philips has launched  the RADIQAL (Radiation Dose and Image Quality Trial) trial. This multicenter, randomized study, sponsored by Philips will enroll 824 coronary artery disease patients across 6 hospitals in Spain, Czech Republic and the US. The first patient in the study was enrolled at Aarhus University Hospital, Denmark.

May 21, 2025 — Konica Minolta Healthcare Americas, Inc and NewVue have announced the introduction of Exa Teleradiology, Powered by NewVue to meet the complex needs of modern teleradiology groups. Designed specifically for distributed reading environments, Exa Teleradiology will streamline the reading experience across multiple systems and facilities, including imaging centers, all delivered through a single cloud-based solution that leverages deeper points of integration than standard interfaced solutions.