FDA

News | X-Ray

Sept. 16, 2026 —DeepHealth has received FDA 510(k) clearance for Chest XRay,¹ a chest X-ray computer-aided detection ...

Time September 18, 2026
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News | PET Imaging

Sept. 15, 2026 — Microstructure Imaging, Inc. (MICSI) has received FDA 510(k) clearance for MICSI-PET, a neurological ...

Time September 15, 2026
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News | Nuclear Imaging

Sept. 08, 2026 — GE HealthCare has announced that StarGuide GX1, its digital 4D CZT SPECT/CT technology, is 510(k) ...

Time September 09, 2026
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News | Computed Tomography (CT)

Aug. 31, 2026 — GE HealthCare recently achieved the CE Mark for Photonova Spectra1, an advanced photon-counting computed ...

Time August 31, 2026
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News | Ultrasound Imaging

Aug. 26, 2026 — ROPCA, a Danish medtech company developing robotic and AI-powered solutions for musculoskeletal ...

Time August 27, 2026
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News | PET Imaging

Aug. 14, 2026 — Lantheus Holdings recently announced U.S. Food and Drug Administration (FDA) approval of Tauklarify ...

Time August 20, 2026
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News | PET Imaging

Aug. 18, 2026 — Cortech.AI's NeuroQuant PET has received FDA 510(k) clearance (K261916) for PET. NeuroQuant PET aids ...

Time August 18, 2026
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News | FDA

Aug. 6, 2026 — Proscia has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Concentriq AP ...

Time August 17, 2026
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News | Digital Pathology

Aug.11, 2026 – Leica Biosystems has received multiple U.S. Food and Drug Administration (FDA) 510(k) clearances that ...

Time August 14, 2026
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News | FDA

Aug. 1, 2026 — Candelis recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance ...

Time August 13, 2026
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News | Cardiac Imaging

Aug. 11, 2026 — Bracco Imaging recently announced that VueJect, its dedicated ultrasound contrast delivery system ...

Time August 12, 2026
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News | Breast Imaging

Aug. 3, 2026 — GE HealthCare has launched Invenia ABUS (Automated Breast Ultrasound) Prime and ABUS StreamVue, a ...

Time August 03, 2026
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News | Breast Imaging

July 30, 2026 — DeepHealth, Inc. has received FDA 510(k) clearance for DeepHealth Breast Ultrasound1, an AI-powered ...

Time July 31, 2026
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News | Cardiac Imaging

July 8, 2026 — Conavi Medical Corp. has announced the publication of a case report in the Journal of the Society for ...

Time July 15, 2026
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News | Breast Imaging

July 7, 2026 — QT Imaging Holdings, Inc. recently announced it has successfully completed its first routine inspection ...

Time July 07, 2026
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News | Mammography

June 30, 2026 — The Food and Drug Administration has cleared new contrast-enhanced mammography (CEM) and CEM biopsy ...

Time June 30, 2026
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News | FDA

June 25, 2026 — Aidoc recently announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device ...

Time June 25, 2026
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News | Computed Tomography (CT)

June 10, 2026 — Subtle Medical has received FDA clearance for SubtleHD (CT), an AI-powered image enhancement solution ...

Time June 17, 2026
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News | Contrast Agents

June 15, 2026 – Bayer has announced that the U.S. Food and Drug Administration (FDA) approved Ambelvist (gadoquatrane) ...

Time June 16, 2026
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News | FDA

June 4, 2026 — GE HealthCare has received 510(k) clearance from the United States Food and Drug Administration (FDA) for ...

Time June 05, 2026
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