After May 30, 2021, the U.S. Food and Drug Administration (FDA) will no longer accept Quality in 510(k) Review Files.  Companies should consider using the electronic Submission Template and Resource (eSTAR).
News | Radiology Imaging
FDA Is Concluding the Quality in 510(k) Review Program Pilot

April 26, 2021 — After May 30, 2021, the U.S. Food and Drug Administration (FDA) will no longer accept Quality in 510(k) ...

Time April 26, 2021
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ACR releases 13 new topics and five revised topics to support referring physicians and other providers in making the most appropriate imaging or treatment decisions
News | Radiology Imaging
American College of Radiology Releases New and Updated ACR Appropriateness Criteria

April 26, 2021 — The American College of Radiology (ACR) released an update to its ACR Appropriateness Criteria (ACR AC) ...

Time April 26, 2021
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A phase 1 clinical trial led by investigators at the University of Chicago Medicine testing the effects of stereotactic body radiotherapy for treating multiple metastases has determined that treatments used for single tumors can also be safely used for treating patients with multiple metastases.
News | Stereotactic Body Radiation Therapy (SBRT)
Study Finds Stereotactic Body Radiotherapy Safe for Treating Patients with Multiple Metastases

April 23, 2021 — A phase 1 clinical trial led by investigators at the University of Chicago Medicine testing the effects ...

Time April 23, 2021
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The Imagio Breast Imaging System combines laser light and sound with conventional ultrasound technology to provide fused functional and anatomic images (referred to as optoacoustic/ultrasound or OA/US) in real time, increasing confidence in diagnostic accuracy.
News | Breast Imaging
FDA Clears Imagio P200003 Breast Imaging System

April 23, 2021 — The U.S. Food and Drug Administration (FDA) has approved Seno Medical's Imagio P200003 Breast Imaging ...

Time April 23, 2021
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A Norwegian study for the first time reveals benefit of the #PARP inhibitor #Olaparib in patients with early #breastcancer not harboring germline mutations
News | Radiation Therapy
New Study Reveals Targeted Therapy Working in Early Breast Cancer

April 22, 2021 — Targeted therapy in early stages of breast cancer can pave the way for a notable higher success rate ...

Time April 22, 2021
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#SBI #NCoBC Studies presented at two leading breast imaging conferences demonstrate ProFound AI helps radiologists identify normal mammograms and those with increased likelihood of malignancy with precision
News | Breast Imaging
New Research Presented on iCAD’s ProFound AI

April 22, 2021 —iCAD, Inc. announced that new research supporting the clinical value of ProFound AI for Digital Breast ...

Time April 22, 2021
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Change Healthcare unveiled InterQual 2021, the latest edition of the company’s flagship clinical decision support solution.
News | Clinical Decision Support
Change Healthcare Launches InterQual 2021 Solution

April 22, 2021 — Change Healthcare unveiled InterQual 2021, the latest edition of the company’s flagship clinical ...

Time April 22, 2021
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Women at high risk of breast cancer face cost-associated barriers to care even when they have health insurance, a new study has found.
News | Women's Health
Insurance Isn't Enough for Women at High Risk of Breast Cancer

April 22, 2021 — Women at high risk of breast cancer face cost-associated barriers to care even when they have health ...

Time April 22, 2021
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Examples of axial FLAIR sequences from studies within dataset A. From left to right: a patient with a 'likely normal' brain; a patient presenting an intraparenchymal hemorrhage within the right temporal lobe; a patient presenting an acute infarct of the inferior division of the right middle cerebral artery; and a patient with known neurocysticercosis presenting a rounded cystic lesion in the left middle frontal gyrus. Image courtesy of Radiological Society of North America
News | Artificial Intelligence
AI-based system could help triage brain MRIs

April 22, 2021 — An artificial intelligence-driven system that automatically combs through brain MRIs for abnormalities ...

Time April 22, 2021
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Spectral DLR enables improved assessment of lumen stenosis in the presence of calcified plaque. Interactive monochromatic image display enables improved opacification of the injected contrast with low keV images and reduced calcium blooming artifacts with high keV images
News | Cardiac Imaging
Canon Medical Receives FDA Clearance on One-beat Spectral Cardiac CT

April 21, 2021 — Meeting the growing cardiovascular needs of healthcare providers today, Canon Medical Systems USA, Inc ...

Time April 21, 2021
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#LG Business Solutions USA has announced the latest in LG’s full line of professional, medical-grade #diagnostic #monitors, the 31-inch, 12-megapixel #31HN713D, which can be used for multiple modes of #diagnostic study, including 3-D #mammography.
News | Flat Panel Displays
LG Expands Diagnostic Medical Monitor Line with New 12-megapixel Multimodality Display

April 21, 2021 — Spurred by the pandemic and the larger trend toward remote work, radiologists have started seeking ...

Time April 21, 2021
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The American College of #Radiology (#ACR) has brought together the full power of its world-class #informatics and #clinical #research resources to launch the innovative #ACR National Clinical Imaging Research Registry (#ANCIRR).
News | Radiology Business
ACR Launches National Clinical Imaging Research Registry

April 21, 2021 — The American College of Radiology (ACR) has brought together the full power of its world-class ...

Time April 21, 2021
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In #partnership with #Ziehm Imaging, #Carestream Health announced the addition of a #mobileCarm into its growing innovative product portfolio. Known as the Ziehm Vision RFD C-arm, this surgical imaging system will further enhance Carestream’s mobile and fluoroscopic product offerings to benefit even more #healthcare providers
News | Mobile C-Arms
Ziehm Imaging Americas and Carestream Announce Distribution Partnership

April 19, 2021 — In partnership with Ziehm Imaging, Carestream Health announced the addition of a mobile C-arm into its ...

Time April 19, 2021
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olecular Targeting Technologies, Inc. (MTTI) announced the issuance of United States Patent # 10,953,113. The patent claims a quick (5 min), easy and quantitative conversion of commercially available 18F-deoxyglucose (18F-FDG) to 18F-Fluroglucaric acid (18F-FGA).
News | PET Imaging
Molecular Targeting Technologies, Inc. Announces New PET Imaging Agent

April 19, 2021 — Molecular Targeting Technologies, Inc. (MTTI) announced the issuance of United States Patent # 10,953 ...

Time April 19, 2021
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The inflamed joints of a #rheumatoid #arthritis patient are clearly visible in the #PET images with the novel 68Ga-DOTA-Siglec-9 #radiopharmaceutical. Image courtesy of Anne Roivainen
News | PET Imaging
Promising Results from First-in-humans Study of a Novel PET Radiopharmaceutical

April 19, 2021 — The preliminary trial results of a novel radiopharmaceutical for PET imaging of inflammation developed ...

Time April 19, 2021
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Low-dose #CT #lung #scans are used to #screen for #lung_cancer in high-risk people such as heavy #smokers
News | Lung Imaging
Lung Cancer Screening Predicts Risk of Death from Heart Disease

April 17, 2021 — A deep learning algorithm accurately predicts the risk of death from cardiovascular disease using ...

Time April 16, 2021
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#NorthStar Medical #Radioisotopes, LLC, a global innovator in the development, production and commercialization of #radiopharmaceuticals used for #medicalimaging and #therapeutic applications, announced a corporate update highlighting progress across its key programs during the past twelve months and upcoming milestones.
News | Radiopharmaceuticals and Tracers
NorthStar Medical Radioisotopes Provides Updates on Corporate Progress

April 16, 2021 — NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and ...

Time April 16, 2021
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the U.S. Food and Drug Administration (#FDA) issued the final rule: #MedicalDevice Classification Regulations to Conform to #Medical #Software Provisions in 21st Century #CuresAct.
News | Information Technology
FDA Issues Final Rule Amending Medical Device Classification Regulations

April 16, 2021 — The U.S. Food and Drug Administration (FDA) issued the final rule: Medical Device Classification ...

Time April 16, 2021
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CDC and FDA Call for Pause on Janssen COVID-19 Vaccine Due to Rare Blood Clots #COVID19 #Janssen
Feature | Coronavirus (COVID-19) | By Dave Fornell
CDC and FDA Call for Pause on Janssen COVID-19 Vaccine Due to Rare Blood Clots

April 15, 2021 — The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) ...

Time April 15, 2021
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#SiemensHealthineers #Varian #Siemens The transformative combination accelerates the company’s impact on #global #healthcare and establishes a strong partner for #customers and #patients along the entire #cancer care continuum and for many of the most threatening #diseases
News | Radiology Business
Siemens Healthineers Completes Acquisition of Varian

April 15, 2021 — Siemens Healthineers AG announced that it has successfully completed the acquisition of Varian Medical ...

Time April 15, 2021
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