FDA

Cerebriu Secures CE Mark for First OEM-Embedded AI Product with Siemens Healthineers

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

Mevion Medical Systems Receives FDA Clearance for Proton Beam Radiation Therapy System

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

FDA Grants 510(k) Clearance to OsteoSight

Sept. 11, 2025 — Naitive Technologies, a medical technology company developing AI-driven software to reimagine ...

September 11, 2025

News | Lung Imaging

Sentec's LuMon Electrical Impedance Tomography System Gets FDA Clearance

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)

FDA Clearance Granted to 4DMedical's CT:VQ

Sept. 4, 2025 — 4DMedical, a global medical technology company, has announced U.S. Food and Drug Administration (FDA) ...

September 04, 2025

News | Cardiac Imaging

GE HealthCare Launches AI-powered Cardiovascular Ultrasound System

Aug. 29, 2025 — GE HealthCare has launched Vivid Pioneer, its most advanced, ultra-premium and adaptive cardiovascular ...

August 29, 2025

Bayer Contrast Agent New Drug Application Accepted for Review by FDA

News | Magnetic Resonance Imaging (MRI)

Bayer Contrast Agent New Drug Application Accepted for FDA Review

Aug. 27, 2025 — Bayer has announced that a New Drug Application (NDA) for its investigational contrast agent ...

August 27, 2025

News | Ultrasound Imaging

Esaote Ultrasound Systems Receive FDA Approval

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

AI-Digital Pathology Software for Prostate Cancer Care Receives FDA De Novo Marketing Authorization

Aug. 13, 2025 — Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive ...

August 15, 2025

Sonic Incytes’ AI-Guided POCUS for Managing Chronic Liver Diseases Gets FDA Nod

News | Point-of-Care Ultrasound (POCUS)

Sonic Incytes’ AI-Guided POCUS Device for Managing Chronic Liver Diseases Gets FDA Nod

Aug. 12, 2025 —Sonic Incytes Medical Corp, has announced that the U.S. Food and Drug Administration (FDA) has granted ...

August 15, 2025

News | Remote Viewing Systems

DeepHealth Secures FDA Clearance for Remote Scanning Solution

August 7, 2025 — DeepHealth, Inc., a wholly-owned subsidiary of RadNet, Inc., announced it has received FDA 510(k) ...

August 07, 2025

News | Breast Imaging

AI-Based Breast Cancer Risk Software Gets FDA Breakthrough Device Designation

July 29, 2025 — A new technology that harnesses AI to analyze mammograms and improve the accuracy of predicting a woman ...

July 30, 2025

News | Prostate Cancer

FDA Grants 510(k) Clearance for Philips' MR/Ultrasound Fusion Guided System

July 23, 2025 — Royal Philips recently announced that the latest Philips UroNav version for image-guided navigation for ...

July 29, 2025

News | Radiation Therapy

Elekta’s Leksell Gamma Knife Receives FDA Clearance

July 23, 2025 — Elekta has received U.S. Food and Drug Administration (FDA) 510(k) clearance to include refractory ...

July 29, 2025

News | X-Ray

GE HealthCare Launches New Digital X-ray System

July 24, 2025 — GE HealthCare has announced the commercial availability of an advanced floor-mounted digital X-ray ...

July 24, 2025

Hyperfine Announces the First Commercial Sales of the Next-Gen Portable MRI System

News | Magnetic Resonance Imaging (MRI)

Hyperfine Announces First Commercial Sales of Next-Gen Portable MRI System

July 17, 2025 – Hyperfine, Inc.recently announced the first commercial sales of the next-generation Swoop system.The ...

July 24, 2025

News | Artificial Intelligence

GE Healthcare Tops FDA List of AI Authorizations

July 22, 2025 — GE HealthCare has topped a U.S. Food and Drug Administration (FDA) list of AI-enabled medical device ...

July 23, 2025

News | Radiographic Fluoroscopy (RF)

Siemens Healthineers Receives FDA Clearance for Two Multifunctional Imaging Platforms

July 21, 2025 — Siemens Healthineers has received Food and Drug Administration clearance for two multifunctional imaging ...

July 21, 2025

News | Prostate Cancer

FDA Grants Breakthrough Device Designation for Artera's AI-Powered Software for Prostate Cancer Care

July 9, 2025 — Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer ...

July 09, 2025

News | FDA

Mendaera Handheld Robotic System Receives FDA Clearance

July 8, 2025 — Mendaera, Inc., a healthcare technology company focused on developing robotics that can be deployed ...

July 08, 2025