FDA

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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Four FDA clearances and 61 EU MDR CE tags achieved for AI in 18 months
News | Artificial Intelligence
Qure.ai Adds New FDA Breakthrough Device Status to Growing List of Regulatory Milestones

February 6, 2024 — Medical imaging AI innovator, Qure.ai, has received breakthrough device designation from the Food and ...

Time February 06, 2024
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Augmento X-Ray is designed to significantly reduce radiologist workload and improve the quality of chest X-ray reporting
News | Artificial Intelligence
DeepTek.ai Unveiled the World's First Commercially Available US FDA Cleared CADe Chest X-Ray AI Solution Covering the Entire Chest Region at RSNA23

February 2, 2024 — DeepTek.ai, a leading provider of artificial intelligence (AI) solutions for medical imaging ...

Time February 02, 2024
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IceCure Medical Ltd. has announced that the Food and Drug Administration (FDA) has granted its appeal and reopened its De Novo Classification Request for Marketing Authorization of its ProSense cryoablation technology for early-stage breast cancer.
News | FDA
FDA Grants IceCure Medical's Appeal: Reopens De Novo Classification Request for Marketing Authorization of ProSense for Early-Stage Breast Cancer

January 30, 2024 — IceCure Medical Ltd. has announced the U.S. Food and Drug Administration (FDA) has responded ...

Time January 30, 2024
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InkSpace Imaging gets FDA clearance for its Siemens 3T MRI compatible Small body array
News | Magnetic Resonance Imaging (MRI)
InkSpace Imaging receives FDA Clearance for a 24-channel Small Body Array Compatible with Siemens Healthineers 3T Systems

January 26, 2024 — InkSpace Imaging, a leader in innovative diagnostic medical device technology, is proud to announce ...

Time January 26, 2024
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RSNA23 kicked off on Nov. 26, welcoming attendees and exhibitors back to another year of showcasing new trends and technology in the field of radiology.
Gallery | RSNA | By Melinda Taschetta-Millane and Christine Book
Photo Gallery of Radiology Technology, Highlights from RSNA 2023

This gallery includes photos of the wide range of medical imaging technologies, scientific sessions, educational courses ...

Time January 26, 2024
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syngo Virtual Cockpit Enables remote scanning and support for up to three scanners simultaneously
News | FDA
Siemens Healthineers Announces FDA Clearance of syngo Virtual Cockpit Remote Scanning Technology

January 23, 2024 — Siemens Healthineers announces the Food and Drug Administration (FDA) clearance of syngo Virtual ...

Time January 23, 2024
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LungQ 3.0.0 builds on 10 years of clinical trials and 200+ publications to deliver advanced segmentation of pulmonary segments and subsegments
News | Artificial Intelligence
Thirona receives FDA 510(k) Clearance for LungQ v3.0.0 Software to Power AI Analysis of Chest CT Images

January 22, 2024 — Thirona, a global company specializing in advanced analysis of thoracic CT images with artificial ...

Time January 22, 2024
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With this new approval, people with a Proclaim DRG neurostimulation system can soon receive full-body MRI scans
News | Magnetic Resonance Imaging (MRI)
Abbott Secures FDA Approval for MRI Labeling Expansion for the Proclaim DRG Neurostimulation System

January 18, 2024 — Abbott announced that the U.S. Food and Drug Administration (FDA) has approved expanded MRI labeling ...

Time January 18, 2024
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Butterfly iQ3 will feature a brand-new ergonomic design, to be revealed soon. (Graphic: Business Wire)
News | Point-of-Care Ultrasound (POCUS)
Butterfly Network Announces FDA Clearance of its Next-generation Handheld Ultrasound System, Butterfly iQ3

January 8, 2024 — Butterfly Network, Inc., a digital health company transforming care through the power of portable ...

Time January 08, 2024
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This reinforces Qure.ai's position as a pioneer in the field of AI-powered advancements for plain film radiography and medical imaging
News | Artificial Intelligence
Qure.ai's AI-Driven Chest X-ray Solution Receives FDA Clearance for Enhanced Lung Nodule Detection

January 8, 2024 — Qure.ai, a leading global innovator in medical imaging solutions, has announced its 13th FDA clearance ...

Time January 08, 2024
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