Nov. 26, 2025 — GE HealthCare has announced it received FDA Premarket Authorization for Pristina Recon DL, an advanced 3D mammography image reconstruction technology.
FDA
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Nov. 25, 2025 —Bracco Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for the Bracco-branded Max 3, a Rapid Exchange and Syringeless Injector for use in magnetic resonance imaging (MRI) procedures.
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Nov 20, 2025 - EDAP TMS SA has announced that the U.S.
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Nov.10, 2025 — Medical imaging technology company Adaptix Ltd. has received 510(k) clearance from the U.S. Food and Drug Administration for its orthopedic 3D imaging product, the Adaptix Ortho350.
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Oct. 30, 2025 — Sirona Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sirona Advanced Imaging Suite, marking a significant regulatory milestone and the company's first Class II medical device designation.
News | Mammography
Nov. 26, 2025 — GE HealthCare has announced it received FDA Premarket Authorization for Pristina Recon DL, an advanced ...
November 29, 2025 
News | FDA
Nov. 25, 2025 —Bracco Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) has expanded the ...
November 26, 2025 
News | FDA
Nov. 25, 2025 — RapidAI has announced the U.S. Food and Drug Administration (FDA) clearance of five new imaging modules ...
November 25, 2025 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 | Ultrasound Imaging
Nov 20, 2025 - EDAP TMS SA has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance ...
November 21, 2025 
News | Radiation Therapy
Nov. 11, 2025 — ZAP Surgical Systems recently announced its ZAP-Axon Radiosurgery Planning System has received both U.S ...
November 14, 2025 
News | Orthopedic Imaging
Nov.10, 2025 — Medical imaging technology company Adaptix Ltd. has received 510(k) clearance from the U.S. Food and Drug ...
November 11, 2025 
News | FDA
Oct. 30, 2025 — Sirona Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sirona ...
October 30, 2025 
News | Cardiac Imaging
Oct. 24, 2025 —YorLabs, Inc., a medical technology company developing next-generation intracardiac imaging solutions for ...
October 27, 2025 
News | Computed Tomography (CT)
Oct. 9, 2025 — Harrison.ai has received three FDA Breakthrough Device Designations for CT imaging solutions, further ...
October 21, 2025 
News | Women's Health
Oct. 3, 2025 — IceCure Medical Ltd., developer of minimally-invasive cryoablation technology that destroys tumors by ...
October 06, 2025 
Oct. 01, 2025 – Nuclidium AG, a clinical-stage radiopharmaceutical company developing a proprietary copper-based ...
October 02, 2025 
Aug. 29, 2025 - Cerebriu recently announced it had received the CE mark for its Apollo Smart Protocol as an OEM-embedded ...
September 19, 2025 
News | Proton Therapy
Sept. 15, 2025 — Mevion Medical Systems announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) ...
September 18, 2025 
News | Bone Densitometry Systems
Sept. 11, 2025 — Naitive Technologies, a medical technology company developing AI-driven software to reimagine ...
September 11, 2025 
News | Lung Imaging
Sept. 4, 2025 — Sentec recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance ...
September 08, 2025 
News | Computed Tomography (CT)
Sept. 4, 2025 — 4DMedical, a global medical technology company, has announced U.S. Food and Drug Administration (FDA) ...
September 04, 2025 
News | Cardiac Imaging
Aug. 29, 2025 — GE HealthCare has launched Vivid Pioneer, its most advanced, ultra-premium and adaptive cardiovascular ...
August 29, 2025 
Aug. 27, 2025 — Bayer has announced that a New Drug Application (NDA) for its investigational contrast agent ...
August 27, 2025 
News | Ultrasound Imaging
Aug. 22, 2025 — Esaote recently announced that the MyLab A50 and MyLab A70 ultrasound systems have received FDA approval ...
August 22, 2025 
News | Prostate Cancer
Aug. 13, 2025 — Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive ...
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