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Management: Food and Drug Administration (FDA)

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Total 16 results found since Jan 2013.

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

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

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The U.S. Food and Drug Administration (FDA) has published a draft guidance...Read more on AuntMinnie.comRelated Reading: Mobile stroke units, spectral CT take spots on ECRI watch list MITA releases cybersecurity white paper at RSNA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

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

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 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

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

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