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Specialty: Radiology
Management: Food and Drug Administration (FDA)

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Total 20 results found since Jan 2013.

Imaging Recommendations for Acute Stroke and Transient Ischemic Attack Patients: A Joint Statement by the American Society of Neuroradiology, the American College of Radiology, and the Society of NeuroInterventional Surgery WHITE PAPER
SUMMARY: Stroke is a leading cause of death and disability worldwide. Imaging plays a critical role in evaluating patients suspected of acute stroke and transient ischemic attack, especially before initiating treatment. Over the past few decades, major advances have occurred in stroke imaging and treatment, including Food and Drug Administration approval of recanalization therapies for the treatment of acute ischemic stroke. A wide variety of imaging techniques has become available to assess vascular lesions and brain tissue status in acute stroke patients. However, the practical challenge for physicians is to understand t...
Source: American Journal of Neuroradiology - November 15, 2013 Category: Radiology Authors: Wintermark, M., Sanelli, P. C., Albers, G. W., Bello, J., Derdeyn, C., Hetts, S. W., Johnson, M. H., Kidwell, C., Lev, M. H., Liebeskind, D. S., Rowley, H., Schaefer, P. W., Sunshine, J. L., Zaharchuk, G., Meltzer, C. C. Tags: WHITE PAPER Source Type: research

FDA clears 2 clot retrieval devices for stroke
The U.S. Food and Drug Administration (FDA) said it has allowed the marketing...Read more on AuntMinnie.comRelated Reading: Mobile stroke units, spectral CT take spots on ECRI watch list New knowledge changes use of CT in guiding stroke treatment Ambulance with mobile CT cuts stroke treatment times Combination of ultrasound, tPA may boost stroke treatment MRI software predicts stroke complications from clot busters
Source: AuntMinnie.com Headlines - September 2, 2016 Category: Radiology Source Type: news

Evolution of Stroke Prevention in Nonvalvular Atrial Fibrillation Patients ∗
The PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trial is the latest in the series of studies evaluating left atrial appendage (LAA) occlusion with the Watchman device (Boston Scientific, Natick, Massachusetts) as an alternative to warfarin therapy for the prevention of stroke in patients with nonvalvular atrial fibrillation (NVAF). The PREVAIL trial was initially designed as a follow-up study to PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation), which demonstrated noninferiority to warfa...
Source: Journal of the American College of Cardiology: Cardiovascular Imaging - July 3, 2014 Category: Radiology Source Type: research

FDA expands use window for stroke treatment device
The U.S. Food and Drug Administration (FDA) has expanded the treatment window...Read more on AuntMinnie.comRelated Reading: FDA clears Viz.AI's stroke detection software Study finds gadolinium leaks into eyes of stroke patients Perfusion imaging expands window for stroke treatment FDA clears 2 clot retrieval devices for stroke Interventionalists: Proceed with caution for mechanical blood clot removal
Source: AuntMinnie.com Headlines - February 15, 2018 Category: Radiology Source Type: news

The Transformation of Our Specialty and Our Relationship with Stroke Care —Adapting to a Changing Landscape
Since the first case series of vertebrobasilar intra-arterial thrombolysis was reported by Zeumer et  al in 1983 (1), catheter-directed management of ischemic stroke has evolved into an effective therapy substantiated by a strong body of evidence—and healthy patients. Initially, catheter-directed thrombectomy, stimulated by the 2004 US Food and Drug Administration approval of the MERCI retriever , was highly controversial. Nevertheless, the performance of intracranial thrombectomy became widespread in the 2000s as a result of pervasive anecdotal evidence of efficacy and a payment structure that incentivized hospitals to...
Source: Journal of Vascular and Interventional Radiology : JVIR - September 1, 2019 Category: Radiology Authors: Laura K. Findeiss Tags: Commentary Source Type: research

Aidoc secures FDA clearance for AI stroke software
The U.S. Food and Drug Administration (FDA) has cleared Israeli artificial...Read more on AuntMinnie.comRelated Reading: Aidoc reports customer milestone Aidoc releases full AI software package for stroke care Aidoc nabs NY contract for AI software FDA clears Aidoc's AI for cervical spine fractures Aidoc scores FDA clearance for pulmonary embolism AI
Source: AuntMinnie.com Headlines - January 13, 2020 Category: Radiology Source Type: news

FDA clears device for reducing stroke risk
The U.S. Food and Drug Administration has cleared a device designed to reduce (more)
Source: AuntMinnie.com Headlines - February 9, 2015 Category: Radiology Source Type: news

FDA releases new cybersecurity recommendations
The U.S. Food and Drug Administration (FDA) has published a draft guidance...Read more on AuntMinnie.comRelated Reading: Mobile stroke units, spectral CT take spots on ECRI watch list MITA releases cybersecurity white paper at RSNA 2015 Yes, you can help prevent healthcare data breaches HIMSS survey finds emphasis on cybersecurity The PACSman at HIMSS 2015: Getting a buzz from buzzwords
Source: AuntMinnie.com Headlines - January 18, 2016 Category: Radiology Source Type: news

FDA OK's Viz.ai's CT software
The U.S. Food and Drug Administration (FDA) has cleared artificial intelligence...Read more on AuntMinnie.comRelated Reading: FDA clears Viz.ai's stroke detection software
Source: AuntMinnie.com Headlines - April 23, 2018 Category: Radiology Source Type: news

FDA works on new regulatory framework for AI
The U.S. Food and Drug Administration (FDA) is working on a new regulatory...Read more on AuntMinnie.comRelated Reading: FDA issues MR thermometry warning FDA proposes new path to 510(k) clearance FDA authorizes ACR to accredit DBT devices FDA releases update on breast implant lymphoma risk FDA clears Viz.ai's stroke detection software
Source: AuntMinnie.com Headlines - April 27, 2018 Category: Radiology Source Type: news

C-MIMI: FDA readies program to speed software reviews
SAN FRANCISCO - The U.S. Food and Drug Administration (FDA) wants to make it...Read more on AuntMinnie.comRelated Reading: Business models emerge for AI in medical imaging Live from C-MIMI: Dr. Bradley Erickson on AI and radiology Live from C-MIMI: Dr. Eliot Siegel on AI and radiology FDA clears Viz.ai's stroke detection software C-MIMI: FDA decision paves the way for imaging AI
Source: AuntMinnie.com Headlines - September 11, 2018 Category: Radiology Source Type: news

FDA to work with tech on digital health innovation
The U.S. Food and Drug Administration (FDA) plans to work with the tech industry...Read more on AuntMinnie.comRelated Reading: C-MIMI: FDA readies program to speed software reviews Business models emerge for AI in medical imaging FDA launches pilot program to expedite 501(k) process FDA clears Viz.ai's stroke detection software C-MIMI: FDA decision paves the way for imaging AI
Source: AuntMinnie.com Headlines - September 13, 2018 Category: Radiology Source Type: news

Effect of Clot Stiffness on Recombinant Tissue Plasminogen Activator Lytic Susceptibility in Vitro
The lytic recombinant tissue plasminogen activator (rt-PA) is the only drug approved by the Food and Drug Administration for treating ischemic stroke. Less than 40% of patients with large vessel occlusions who are treated with rt-PA have improved blood flow. However, up to 6% of all patients receiving rt-PA develop intracerebral hemorrhage. Predicting the efficacy of rt-PA treatment a priori could help guide therapeutic decision making, such that rt-PA is administered only to those individuals who would benefit from this treatment.
Source: Ultrasound in Medicine and Biology - September 26, 2018 Category: Radiology Authors: Karla P. Mercado-Shekhar, Robert T. Kleven, Hermes Aponte Rivera, Ryden Lewis, Kunal B. Karani, Hendrik J. Vos, Todd A. Abruzzo, Kevin J. Haworth, Christy K. Holland Tags: Original Contribution Source Type: research

FDA clears Siemens' mobile x-ray system
Siemens Healthineers has received clearance from the U.S. Food and Drug Administration...Read more on AuntMinnie.comRelated Reading: Siemens to debut cardio edition of go.TOP CT at ACC Siemens and MRI Interventions sign MRI deal Siemens VP Darrow dies Siemens, Allm partner on mobile image sharing iSchemaView, Siemens team up on stroke imaging
Source: AuntMinnie.com Headlines - March 20, 2019 Category: Radiology Source Type: news

FDA clears Infervision's lung CT AI software
The U.S. Food and Drug Administration (FDA) has cleared Infervision's lung...Read more on AuntMinnie.comRelated Reading: AlgoMedica, InferVision partner on imaging AI software Infervision launches AI software to detect coronavirus Infervision unveils AI app, RSNA sessions AI firm Infervision scores $47M in funding Infervision debuts AI stroke screening software
Source: AuntMinnie.com Headlines - July 10, 2020 Category: Radiology Source Type: news