July 8, 2025 — Mendaera, Inc., a healthcare technology company focused on developing robotics that can be deployed universally in medicine, recently announced it has received U.S.
FDA
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July 2, 2025 — Philips has received FDA 510(k) clearance for SmartSpeed Precise[1] MR’s latest deep learning reconstruction software, marking a major milestone in the journey toward autonomous, personalized MRI.
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June 26, 2025 — Siemens Healthineers has received Food and Drug Administration clearance for the Magnetom Flow.Ace, its first 1.5 tesla (T) platform for magnetic resonance (MR) imaging with a closed helium circuit and no quench pipe, significantly reducing reliance on helium.
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Jun. 24, 2025 — GE HealthCare has announced that the U.S. Food and Drug Administration (FDA) approved an updated label for its positron emission tomography (PET) imaging agent Vizamyl (flutemetamol F 18 injection) for beta-amyloid detection.
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June 24, 2025 —Smart Soft Healthcare has announced that CoLumbo, the company's advanced AI spine assistant, has received FDA 510(K) clearance for its latest version, Version 3.
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
July 8, 2025 — Mendaera, Inc., a healthcare technology company focused on developing robotics that can be deployed ...
July 08, 2025 
July 2, 2025 — Philips has received FDA 510(k) clearance for SmartSpeed Precise[1] MR’s latest deep learning ...
July 03, 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 
June 26, 2025 — Siemens Healthineers has received Food and Drug Administration clearance for the Magnetom Flow.Ace, its ...
June 26, 2025 
News | PET Imaging
Jun. 24, 2025 — GE HealthCare has announced that the U.S. Food and Drug Administration (FDA) approved an updated label ...
June 24, 2025 
June 24, 2025 —Smart Soft Healthcare has announced that CoLumbo, the company's advanced AI spine assistant, has received ...
June 24, 2025 
News | Contrast Media
June 17, 2025 — Bayer has announced the submission of a New Drug Application (NDA) to the US Food and Drug ...
June 20, 2025 
June 17, 2025 — Royal Philips has announced the global launch of the Flash Ultrasound System 5100 POC — a new point-of ...
June 19, 2025 
News | Lung Imaging
June 18, 2025 — Exo recently announced that now included on its Exo Iris is the first ever FDA 510(k) cleared AI for ...
June 18, 2025 
News | Breast Imaging
June 2, 2025 — Clairity, Inc., a digital health innovator advancing AI-driven healthcare solutions, has received U.S ...
June 02, 2025 
May 29, 2025 — Hyperfine, Inc., producer of the world’s first FDA-cleared AI-powered portable MRI system for the brain — ...
May 29, 2025 
News | Pediatric Imaging
May 13, 2025-- GE HealthCare recently announced the U.S. Food and Drug Administration (FDA) has approved a pediatric ...
May 20, 2025 
News | Cardiac Imaging
May 19, 2025 - Arineta, a provider of cardiovascular imaging solutions, recently announced that its SpotLight Duo ...
May 19, 2025 
News | Computed Tomography (CT)
May 15, 2025 — GE HealthCare has launched CleaRecon DL, technology powered by a deep-learning algorithm, to improve the ...
May 15, 2025 
May 12, 2025 — GE HealthCare recently unveiled Signa Sprint, an FDA 510(k) pending[1] ultra-premium wide bore 1.5T high ...
May 12, 2025 
News | Nuclear Imaging
May 5, 2025 — GE HealthCare recently announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance ...
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News | Radiation Oncology
May 2, 2025 — GE HealthCare has announced an intended expansion of its radiation oncology portfolio as well as the ...
May 03, 2025 
News | Computed Tomography (CT)
April 17, 2025 — Nano-X Imaging LTD has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for ...
April 18, 2025 
News | Breast Imaging
April 15, 2025 — CureMetrix, a provider of AI-driven medical imaging solutions, has announced that its AI-based cmAngio ...
April 17, 2025 
News | Radiation Dose Management
April 7, 2025 — DOSIsoft, a provider of patient-specific imaging and dosimetry software solutions, recently announced ...
April 08, 2025