Oct. 15, 2026— SimBioSys has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of TumorSight Risk, its AI-powered, MRI-derived prognostic tool for assessing breast cancer recurrence risk.
FDA
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Sept. 08, 2026 — GE HealthCare has announced that StarGuide GX1, its digital 4D CZT SPECT/CT technology, is 510(k) pending with the U.S. Food and Drug Administration (FDA).
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Aug. 14, 2026 — Lantheus Holdings recently announced U.S.
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Aug. 18, 2026 — Cortech.AI's NeuroQuant PET has received FDA 510(k) clearance (K261916) for PET.
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Aug. 11, 2026 — Bracco Imaging recently announced that VueJect, its dedicated ultrasound contrast delivery system engineered to support cardiology imaging specifically, has received 510(k) clearance from the U.S.
News | Women's Health
Oct. 15, 2026— SimBioSys has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of TumorSight Risk, its ...
October 19, 2026 
News | FDA
Oct.7, 2026 – MRI2CT Inc. has received FDA 510(k) clearance for NextMR, its AI powered imaging platform, for generating ...
October 07, 2026 
News | Pediatric Imaging
Sept. 29, 2026 — Visiana has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for ...
October 02, 2026 Sponsored Content
News | Computed Tomography (CT)
SPONSORED CONTENT — Fujifilm’s latest CT technology brings exceptional image quality to a compact and user- and patient ...
August 06, 2024 
News | Computed Tomography (CT)
Sept. 21, 2026 — a2z Radiology AI has announced FDA clearance of a2z-Abdo-Triage for 10 findings on abdomen-pelvis CT ...
September 21, 2026 
News | Radiation Oncology
Sept.21, 2026 — Radformation, a provider of intelligent automation solutions for radiation oncology, has expanded U.S ...
September 21, 2026 
News | X-Ray
Sept. 16, 2026 —DeepHealth has received FDA 510(k) clearance for Chest XRay,¹ a chest X-ray computer-aided detection ...
September 18, 2026 
News | PET Imaging
Sept. 15, 2026 — Microstructure Imaging, Inc. (MICSI) has received FDA 510(k) clearance for MICSI-PET, a neurological ...
September 15, 2026 
News | Nuclear Imaging
Sept. 08, 2026 — GE HealthCare has announced that StarGuide GX1, its digital 4D CZT SPECT/CT technology, is 510(k) ...
September 09, 2026 
News | Computed Tomography (CT)
Aug. 31, 2026 — GE HealthCare recently achieved the CE Mark for Photonova Spectra1, an advanced photon-counting computed ...
August 31, 2026 
News | Ultrasound Imaging
Aug. 26, 2026 — ROPCA, a Danish medtech company developing robotic and AI-powered solutions for musculoskeletal ...
August 27, 2026 
News | PET Imaging
Aug. 14, 2026 — Lantheus Holdings recently announced U.S. Food and Drug Administration (FDA) approval of Tauklarify ...
August 20, 2026 
News | PET Imaging
Aug. 18, 2026 — Cortech.AI's NeuroQuant PET has received FDA 510(k) clearance (K261916) for PET. NeuroQuant PET aids ...
August 18, 2026 
News | FDA
Aug. 6, 2026 — Proscia has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Concentriq AP ...
August 17, 2026 
News | Digital Pathology
Aug.11, 2026 – Leica Biosystems has received multiple U.S. Food and Drug Administration (FDA) 510(k) clearances that ...
August 14, 2026 
News | FDA
Aug. 1, 2026 — Candelis recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance ...
August 13, 2026 
News | Cardiac Imaging
Aug. 11, 2026 — Bracco Imaging recently announced that VueJect, its dedicated ultrasound contrast delivery system ...
August 12, 2026 
News | Breast Imaging
Aug. 3, 2026 — GE HealthCare has launched Invenia ABUS (Automated Breast Ultrasound) Prime and ABUS StreamVue, a ...
August 03, 2026 
News | Breast Imaging
July 30, 2026 — DeepHealth, Inc. has received FDA 510(k) clearance for DeepHealth Breast Ultrasound1, an AI-powered ...
July 31, 2026 
News | Cardiac Imaging
July 8, 2026 — Conavi Medical Corp. has announced the publication of a case report in the Journal of the Society for ...
July 15, 2026 
News | Breast Imaging
July 7, 2026 — QT Imaging Holdings, Inc. recently announced it has successfully completed its first routine inspection ...
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