FDA

Elekta Instrument AB recalls disposable biopsy needle kit for Leksell Stereotactic System for possibly containing microscopic stainless steel febris on the inside of the biopsy needle
News | FDA
FDA Announces Elekta Recall of Biopsy Needle Kit for Leksell Stereotactic System

April 29, 2024 — The U.S. Food and Drug Administration (FDA) announced Elekta Instrument AB is recalling Disposable ...

Time April 29, 2024
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FDA clearance makes image-guided surgical procedures available to more US patients at lower cost
News | FDA
Philips Zenition 30 Mobile C-arm Receives FDA 510(k) Clearance

April 23, 2024 — Royal Philips , a global leader in health technology, today announced its Philips Zenition 30 mobile C ...

Time April 23, 2024
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LUMISIGHT and Lumicell Direct Visualization System (DVS) offer 84% diagnostic accuracy in detecting residual cancer, in real-time, that may have been otherwise missed during lumpectomy surgery, while sparing some from second surgeries
News | FDA
Lumicell’s Cutting-Edge Imaging Platform Receives Historic FDA Approval to Illuminate Residual Breast Cancer

April 18, 2024 — Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging ...

Time April 18, 2024
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First completely redesigned mammography platform in over a decade
News | Mammography
Siemens Healthineers Receives FDA 510(k) Clearance for MAMMOMAT B.brilliant Mammography System

April 4, 2024 — Siemens Healthineers announces the Food and Drug Administration 510(k) clearance of the MAMMOMAT B ...

Time April 04, 2024
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Here is a look at the most-read content during the month of March on itnonline.com
Feature | Radiology Business | By Melinda Taschetta-Millane
Top 10: Must-reads from the Month of March

Here is a snapshot of the Top 10 most-read content from ITN's viewers during the month of March: 1. Philips Teams with ...

Time April 04, 2024
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Enabling off-site experts to remotely provide real-time guidance to the licensed technologist operating the scanner
News | Radiology Imaging
GE HealthCare Announces the FDA Clearance of nCommand Lite by IONIC Health

April 3, 2024 — GE HealthCare announced the U.S. FDA 510(k) Clearance of IONIC Health’s nCommand Lite technology. The ...

Time April 03, 2024
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Delivers higher image resolution and visualization of smaller structures
News | Magnetic Resonance Imaging (MRI)
Siemens Healthineers Announces FDA Clearance of MAGNETOM Terra.X 7-Tesla Magnetic Resonance Scanner

March 27, 2024 — Siemens Healthineers announces the Food and Drug Administration (FDA) clearance of the MAGNETOM Terra.X ...

Time March 27, 2024
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SyntheticMR announced today that their next-generation imaging solution with isotropic resolution, SyMRI 3D, has received FDA 510(k) clearance for clinical use in the United States
News | FDA
SyntheticMR Receives FDA 510(k) Clearance for its Next Generation Solution SyMRI 3D

March 27, 2024 — SyntheticMR announced that its next-generation imaging solution, SyMRI 3D, has received FDA 510(k) ...

Time March 27, 2024
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Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the CIARTIC Move, a mobile C-arm with self-driving capabilities.
News | FDA
Siemens Healthineers Announces FDA Clearance of CIARTIC Move Self-Driving Mobile C-arm

March 21, 2024 — Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the CIARTIC Move ...

Time March 21, 2024
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For the first time in a commercial setting, physicians are able to see the extent of disease and provide more personalized and precise treatments for prostate cancer patients using AI
News | Artificial Intelligence
Avenda Health Announces First Commercial Use of Unfold AI on Prostate Cancer Patients in the US

March 21, 2024 — Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care ...

Time March 21, 2024
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AI, including machine learning (ML), spans transformative technologies with the potential to revolutionize healthcare
News | Artificial Intelligence
Artificial Intelligence Paper Outlines FDA’s Approach to Protect Public Health and Promote Ethical Innovation

March 15, 2024 — Today, the U.S. Food and Drug Administration (FDA) released its “Artificial Intelligence and Medical ...

Time March 15, 2024
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Medical imaging AI company DeepTek.ai will showcase its groundbreaking US FDA-cleared chest X-ray reporting AI solution, Augmento X-Ray, during HIMSS 2024 being held March 11-15 in Orlando, FL.
News | HIMSS
Deetptek.ai Showcases Chest X-ray AI solution, Augmento X-ray, at HIMSS 2024

March 8, 2024 — DeepTek.ai, a leading medical imaging AI company, will showcase its groundbreaking US FDA-cleared chest ...

Time March 08, 2024
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Lumicell announced the Medical Imaging Drugs Advisory Committee (MIDAC) of the U.S Food and Drug Administration (FDA) voted in support of the benefit-risk profile of LUMISIGHT
News | Breast Imaging
Lumicell Announces FDA Advisory Committee’s Positive Recommendation on the Benefit-Risk Profile of LUMISIGHT in the Detection of Cancerous Tissue During Breast Conserving Surgery

March 8, 2024 — Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies ...

Time March 08, 2024
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Lantheus announced that the U.S. Food and Drug Adminstration (FDA) has approved DEFINITY (Perflutren Lipid Microsphere) as an ultrasound enhancing agent for use in pediatric patients with suboptimal echocardiograms, including those who have undergone heart transplant, or have Kawasaki disease or a congenital cardiovascular anomaly.
News | FDA
Lantheus Announces the FDA Approval of DEFINITY as Ultrasound Enhancing Agent for Use in Certain Pediatric Cardiovascular Patients

March 6, 2024 — Lantheus Holdings, Inc. (Lantheus), a radiopharmaceutical company, has announced that the U.S. Food and ...

Time March 06, 2024
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HyperSight is designed to enhance accuracy in delivering radiotherapy treatments, with the goal of effective protection of healthy tissues
News | FDA
Varian Receives FDA 510(k) Clearance for TrueBeam and Edge Radiotherapy Systems Featuring HyperSight Imaging Solution

March 1, 2024 — Varian, a Siemens Healthineers company, announced that it has received 510(k) clearance from the U.S ...

Time March 01, 2024
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The FDA recalls the Philips BrightView XCT
News | SPECT Imaging
Philips Recalls BrightView Imaging Systems Due to the Detector Unexpectedly Falling

February 15, 2024 — According to a release issued by the U.S. Food and Drug Administration (FDA), Philips is recalling ...

Time February 15, 2024
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New guidance system marks significant advancement in breast cancer care, targeting tumor location in multiple dimensions for precise excision and successful surgeries
News | FDA
Merit Medical Receives FDA 510(k) Clearance for SCOUT MD Surgical Guidance System

February 15, 2024 — Merit Medical Systems, Inc., a global leader of healthcare technology, has received US Food and Drug ...

Time February 15, 2024
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Butterfly iQ3 is built on the next-generation P4.3 Ultrasound-on-Chip technology with the world’s fastest digital data transfer, enhancing frame rates, frequency and new 3D imaging capabilities – all on a smaller, lighter and more ergonomically designed probe
News | Point-of-Care Ultrasound (POCUS)
Butterfly Network Launches Next-Generation Butterfly iQ3 in the United States

February 13, 2024 — Butterfly Network, Inc., a digital health company transforming care through the power of portable ...

Time February 13, 2024
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Nanox’s HealthFLD is pioneering the use of a fully automated AI software for liver attenuation analysis from CT scans that has received FDA 510(k) clearance for use in general population
News | Artificial Intelligence
Nanox Receives FDA Clearance for HealthFLD, an Advanced AI-Based Software Empowering Clinicians in Assessment of Fatty Liver

February 13, 2024 — Nanox, an innovative medical imaging technology company, today announced that its deep-learning ...

Time February 13, 2024
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Proscia, a software company accelerating the transformation to digital pathology, has announced its receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Concentriq AP-Dx for the purpose of primary diagnosis.
News | FDA
Proscia Receives FDA Clearance for Digital Pathology Software Solution

February 12, 2024 — Proscia, a leading provider of digital and computational pathology solutions, has received 510(k) ...

Time February 12, 2024
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