Search Tag: FDA

IMAGING Management

Us-fda-approves-worlds-first-photon-counting-ct-system

2021 06 Oct

On September 30, the US FDA approved the Siemens Naeotom Alpha, the world’s first photon-counting computed tomography (CT) scanner through the 510(k) premarket clearance pathway. 510(k) clearance establishes that a medical device is equivalent to a legally marketed predicate device. FDA and CT experts consider this a revolutionary shift in CT scanner...Read more

IMAGING Management

Fda-amends-emergency-use-authorization-for-hologics-aptima-sars-cov-2-assay

2020 06 Oct

Hologic, Inc.  announced today that its Aptima® SARS-CoV-2 assay, which initially received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in May, is now authorized for testing of individuals without symptoms or other reasons to suspect COVID-19 infection. This authorization follows an  announcement  last week...Read more

IMAGING Management

Ecr2019-paediatric-ceus-a-fantastic-tool

2019 06 Mar

Dr.  Paul Sidhu , professor of Imaging Sciences and Consultant Radiologist King’s College London , UK, and President Elect of the European Federation of Societies for Ultrasound in Medicine and Biology ( EFSUMB ) presented the Luigi Oliva Honorary Lecture at ECR2019 .   Professor Sidhu opened his lecture saying “I fully appreciate that ultrasound...Read more

IMAGING Management

5th-digital-pathology-ai-congress-usa

2019 13 Jun

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IMAGING Management

Mri-guided-ultrasound-to-treat-tremor-gets-ok-from-fda

2016 12 Jul

The U.S. Food and Drug Administration ( FDA ) has given the green light to a focused ultrasound device that uses magnetic resonance (MR) images taken during the procedure to treat essential tremor in patients who have not responded to medication. ExAblate Neuro, manufactured by InSightec in Dallas, Texas, delivers focused ultrasound to destroy...Read more

IMAGING Management

Eos-imaging-reports-2014-financial-results-and-q1-2015-revenue

2015 23 Apr

Strong growth in 2014 revenues: up 32% Continued improvement in gross margin: up 400 basis points Q1 2015 revenues increase 53% driven by USA EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopaedic medical imaging, announced its consolidated annual results for the year ended December 31, 2014, as approved by...Read more

IMAGING Management

Resolutionmd-first-to-receive-china-fda-certification-for-web-and-mobile-diagnosis

2014 22 Apr

Calgary Scientific Inc., a company known for creating transformative technology for the medical industry and beyond, has announced that ResolutionMD® is first to receive certification from the China Food and Drug Administration (CFDA) for diagnosis on both web and mobile devices for all imaging modalities.  This certification enables medical...Read more

IMAGING Management

Fda-clearance-awarded-to-calgary-scientific-for-mobile-diagnosis-on-all-modalities

2014 19 Apr

Calgary Scientific Inc., a company known for creating transformative technology for the medical industry and beyond, has announced their latest Class II clearance from the United States (US) Food and Drug Administration (FDA).  The leading enterprise image-viewing solution, ResolutionMD® is now cleared for diagnosis on mobile devices, for all...Read more

IMAGING Management

Fda-clearance-awarded-to-siemens-cios-alpha-mobile-c-arm

2014 09 Apr

FDA Clears Siemens’ Cios Alpha Mobile C-arm with Flat-Panel Detector Combination of detector and 25 kW power output yield high-resolution, high-contrast images Field of view up to 25% larger than conventional C-arms Siemens Healthcare has announced that the Food and Drug Administration (FDA) has cleared the Cios Alpha, a dynamic...Read more

IMAGING Management

Colon-camera-pill-receives-us-fda-approval

2014 05 Feb

Camera-in-a-pill manufacturer Given Imaging announced that it received US Food and Drug Administration clearance for a pill able to provide visualisation of the colon, making it available to a global market of 3 million procedures per year. The pill, a swallowed capsule endoscope entitled PillCam Colon, is designed for the detection of colon...Read more

IMAGING Management

Siemens-awarded-us-fda-approval-for-rt-pro-workflow-features

2014 27 Jan

FDA Clears Siemens RT Workflow Features RT Pro edition enhances radiation oncology workflow on company’s SOMATOM Definition AS Open CT simulator Siemens Healthcare has announced that the US Food and Drug Administration (FDA) has cleared the RT Pro edition – a package of features designed to enhance radiation oncology workflow for Siemens’...Read more