Jan. 20, 2026 — Hyperfine, the developer of the first FDA-cleared AI-powered portable MRI system for the brain — the Swoop system — has announced results from the NEURO PMR study, presented by Dr. Laszlo Mechtler at the American Society of Neuroimaging (ASN) meeting in San Juan, Puerto Rico on Jan. 16, 2026.

Jan. 16, 2026 — Vega Imaging Informatics has announced the successful curation of the world’s largest digital breast tomosynthesis (DBT) dataset with paired histology outcomes. The dataset was prepared for a leading developer of AI-based radiology software focused on breast imaging and will support the development of next-generation AI solutions designed to assist in the interpretation of 3D mammography exams.

Jan. 14, 2026 — VizMark has received U.S. Food and Drug Administration FDA 510k clearance for VM1, a non-metal visual tumor marker designed to provide artifact-free visibility across all major breast imaging modalities, including MRI, mammography, X-ray, CT and ultrasound.

VM1 was developed to address long-standing limitations of metallic markers, which can create artifacts on MRI and complicate imaging follow-up, particularly for patients undergoing multimodal or high-risk surveillance.

Jan. 16, 2026 — Elekta has announced that its Elekta Evo* CT-Linac has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This milestone makes the system available to radiation oncology professionals in the United States.

Jan. 16, 2026 — In a proof-of-concept study funded by the National Institutes of Health, researchers from the Keck School of Medicine of USC and the California Institute of Technology (Caltech) have shown that an innovative, noninvasive technique can be used to quickly collect 3D images of the human body, from head to foot. The technology combines ultrasound and photoacoustic imaging, which detects sound waves generated by light, to simultaneously collect images of both tissue and blood vessels.

Jan. 14, 2026 — Susan G. Komen, the world’s leading breast cancer organization commends Assemblymember Lori Wilson (D-Suisun City) for introducing legislation to ensure equitable access to required diagnostic and supplemental breast imaging, by eliminating the financial barriers patients face in accessing needed breast cancer screening.

Jan. 13, 2026 — A streamlined, nurse-led response for hospitalized patients experiencing an acute stroke at a Texas academic medical center improved time from symptom discovery to imaging and treatment, which is associated with better outcomes.

Jan. 14, 2026 — iSono Health has announced the commercial launch of ATUSA, an FDA-cleared, wearable and automated 3D quantitative breast ultrasound platform. Designed to bring high-quality imaging into everyday clinics, ATUSA unlocks the $14B U.S. breast imaging market by eliminating reliance on hard-to-find skilled sonographers and cost-prohibitive equipment.

A Paradigm Shift

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