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

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Total 20 results found since Jan 2013.

FDA clears RapidAI's CT imaging stroke assessment software
The U.S. Food and Drug Administration (FDA) has cleared artificial intelligenc...Read more on AuntMinnie.comRelated Reading: RapidAI receives FDA clearance for Rapid RV/LV RapidAI gets FDA nod for ICH algorithm RapidAI earns FDA clearance for PE triage software RapidAI names Phadnis as new technology executive RapidAI taps Karim Karti as its new CEO
Source: AuntMinnie.com Headlines - April 18, 2023 Category: Radiology Source Type: news

Samsung NeuroLogica nets FDA clearance for AI tool
Samsung NeuroLogica has received U.S. Food and Drug Administration (FDA) 510(k...Read more on AuntMinnie.comRelated Reading: Samsung NeuroLogica gets nod for ultrasound sales to U.S. military NeuroLogica launches new mobile stroke CT scanner NeuroLogica boosts CT manufacturing for virus scanning RapidAI debuts technology partner program, API Samsung NeuroLogica lands Memorial Sloan Kettering
Source: AuntMinnie.com Headlines - October 29, 2021 Category: Radiology Source Type: news

Samsung NeuroLogica gets FDA nod for AI tool
Samsung NeuroLogica has received U.S. Food and Drug Administration (FDA) 510(k...Read more on AuntMinnie.comRelated Reading: Samsung NeuroLogica gets nod for ultrasound sales to U.S. military NeuroLogica launches new mobile stroke CT scanner NeuroLogica boosts CT manufacturing for virus scanning RapidAI debuts technology partner program, API Samsung NeuroLogica lands Memorial Sloan Kettering
Source: AuntMinnie.com Headlines - October 28, 2021 Category: Radiology Source Type: news

FDA approves expanded labeling for Medtronic's MRI leads
The U.S. Food and Drug Administration (FDA) has approved expanded labeling fo...Read more on AuntMinnie.comRelated Reading: 1st patient implanted in Medtronic's ELITE study Medtronic recalls StealthStation DBS software Medtronic, Viz.ai team up on stroke care Philips inks Medtronic collaboration Medtronic recalls StealthStation brain imaging software
Source: AuntMinnie.com Headlines - February 18, 2021 Category: Radiology Source Type: news

FDA clears use of MRI for Impulse Dynamics' Optimizer
The U.S. Food and Drug Administration (FDA) has cleared for conditional use...Read more on AuntMinnie.comRelated Reading: Socioeconomic status predicts heart failure mortality AI predicts heart attack, stroke on cardiac MRI MRI discovers heart damage among male triathletes
Source: AuntMinnie.com Headlines - January 20, 2021 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

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

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

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

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 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

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 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

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 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