FDA

FDA Clears GE HealthCare's MIM LesionID Pro
News | FDA
FDA Clears GE HealthCare's MIM LesionID Pro

Jan. 29, 2026 — GE HealthCare has received 510(k) clearance from the FDA Clears U.S. Food and Drug Administration (FDA) ...

Time February 03, 2026
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Imagion Biosystems Submits IND Application to FDA for Targeted Imaging Agent
News | FDA
Targeted Imaging Agent Submitted to FDA for IND Application

Feb. 2, 2026 — Imagion Biosystems, Ltd. has submitted an Investigational New Drug (IND) application with the U.S. Food ...

Time February 02, 2026
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Allia Moveo Platform from GE Healthcare Receives FDA Clearance, CE Mark
News | Interventional Radiology
Allia Moveo Platform from GE Healthcare Receives FDA Clearance, CE Mark

Feb. 2, 2026 — GE HealthCare has announced that Allia Moveo has received U.S. Food and Drug Administration (FDA) 510(k) ...

Time February 02, 2026
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FDA Clears Comprehensive Foundation Model AI for Abdomen CT
News | Computed Tomography (CT)
FDA Clears Comprehensive Foundation Model AI for Abdomen CT

Jan. 21, 2026 — Aidoc recently announced that the U.S. Food and Drug Administration (FDA) cleared the industry's first ...

Time January 23, 2026
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VizMark Secures FDA Clearance for Visual Tumor Marker
News | Breast Imaging
VizMark Secures FDA Clearance for Visual Tumor Marker

Jan. 14, 2026 — VizMark has received U.S. Food and Drug Administration FDA 510k clearance for VM1, a non-metal visual ...

Time January 19, 2026
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News | Radiation Therapy
Elekta Gets FDA 510(k) Clearance for Linear Accelerator

Jan. 16, 2026 — Elekta has announced that its Elekta Evo* CT-Linac has received 510(k) clearance from the U.S. Food and ...

Time January 16, 2026
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FDA Clears Siemens Healthineers' 70 cm Magnetom Flow. Platform
News | Magnetic Resonance Imaging (MRI)
FDA Clears Siemens Healthineers' 70 cm Magnetom Flow. Platform

Jan. 8, 2026 — Siemens Healthineers has received Food and Drug Administration clearance for the 70 cm bore Magnetom Flow ...

Time January 08, 2026
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Hyperfine Receives FDA Clearance for Software Update for Portable MRI System for the Brain
News | Stroke
Hyperfine Receives FDA Clearance for Software Update for Portable MRI System for the Brain

Dec. 12, 2025 — Hyperfine, Inc. has announced that it has received FDA clearance for a new multi-direction diffusion ...

Time December 15, 2025
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Lunit Files FDA 510(k) for AI Mammography-Based Risk Prediction Model
News | FDA
Lunit Files FDA 510(k) for AI Mammography-Based Risk Prediction Model

Dec. 8, 2025 — Lunit, a provider of AI for cancer diagnostics and precision oncology, has submitted a 510(k) premarket ...

Time December 08, 2025
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Canon Announces Global Launch of Alphenix 4D CT with Aquilion ONE/INSIGHT Edition for Interventional Procedures
News | Computed Tomography (CT)
Canon Announces Global Launch of Alphenix 4D CT with Aquilion ONE/INSIGHT Edition for Interventional Procedures

Dec,. 1, 2025 — Canon has announced that the U.S. Food and Drug Administration (FDA) has granted [510(k) clearance/PMA ...

Time December 04, 2025
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FDA Approves IDE Application to Initiate Trial for Treating Locally Recurrent Prostate Cancer
News | FDA
FDA Approves IDE Application to Initiate Trial for Treating Locally Recurrent Prostate Cancer

Dec. 02, 2025 — Alpha Tau Medical Ltd., the developer of the alpha-radiation cancer therapy Alpha DaRT, has announced ...

Time December 04, 2025
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FDA Grants Clearance to a2z Radiology AI for Unified-Triage
News | FDA
FDA Grants Clearance to a2z Radiology AI for Unified-Triage

Nov. 26, 2025 — a2z Radiology AI has received U.S. FDA clearance for a2z-Unified-Triage, a single device that flags and ...

Time December 03, 2025
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GE Healthcare to Unveil Advanced 3D Mammography Image Reconstruction Technology
News | Mammography
GE Healthcare to Unveil Advanced 3D Mammography Image Reconstruction Technology

Nov. 26, 2025 — GE HealthCare has announced it received FDA Premarket Authorization for Pristina Recon DL, an advanced ...

Time November 29, 2025
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Bracco's Syringeless MR Injector Receives FDA Approval
News | FDA
Bracco's Syringeless MR Injector Receives FDA Approval

Nov. 25, 2025 —Bracco Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) has expanded the ...

Time November 26, 2025
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News | FDA
RapidAI Receives FDA Clearance on Five Products

Nov. 25, 2025 — RapidAI has announced the U.S. Food and Drug Administration (FDA) clearance of five new imaging modules ...

Time November 25, 2025
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EDAP Secures FDA Clearance for HIFU System's Latest Enhancements
News | Ultrasound Imaging
EDAP Secures FDA Clearance for HIFU System's Latest Enhancements

Nov 20, 2025 - EDAP TMS SA has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance ...

Time November 21, 2025
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ZAP Surgical’s Radiosurgery Planning System Receives FDA 510(k),  E.U. CE Clearance
News | Radiation Therapy
Radiosurgery Planning System Receives FDA 510(k), CE Clearance

Nov. 11, 2025 — ZAP Surgical Systems recently announced its ZAP-Axon Radiosurgery Planning System has received both U.S ...

Time November 14, 2025
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FDA Grants 510(k) Clearance to Adaptix Ortho350
News | Orthopedic Imaging
FDA Grants 510(k) Clearance to Adaptix Ortho350

Nov.10, 2025 — Medical imaging technology company Adaptix Ltd. has received 510(k) clearance from the U.S. Food and Drug ...

Time November 11, 2025
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Sirona Advanced Imaging Suite Gets FDA 510(k) Clearance
News | FDA
Sirona Advanced Imaging Suite Gets FDA 510(k) Clearance

Oct. 30, 2025 — Sirona Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sirona ...

Time October 30, 2025
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Intracardiac Imaging System Gets FDA 510(k) Clearance
News | Cardiac Imaging
Intracardiac Imaging System Gets FDA 510(k) Clearance

Oct. 24, 2025 —YorLabs, Inc., a medical technology company developing next-generation intracardiac imaging solutions for ...

Time October 27, 2025
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