Regulatory: Page 27

Behold.ai wins FDA approval for red dot AI algorithm
By AuntMinnie.com staff writers
U.K. artificial intelligence (AI) software developer Behold.ai has received U.S. Food and Drug Administration (FDA) clearance for its red dot AI triage algorithm.
March 11, 2020
2020 02 20 00 48 1332 Approved Stamp 400
FDA pauses international inspections due to COVID-19
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) said it is postponing all inspections outside of the U.S. through April due to the outbreak of the novel coronavirus disease (COVID-19).
March 9, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
FDA recognizes AI-based image acquisition software
By Erik L. Ridley
The U.S. Food and Drug Administration (FDA) created a new regulatory classification for artificial intelligence (AI)-guided image acquisition and optimization software earlier in February when it cleared a new AI-based echocardiography acquisition application. An FDA representative detailed the new rule in a talk Wednesday at a public workshop.
February 27, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
FDA proposes electronic 510(k) submission template
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) is considering a new optional electronic 510(k) submission template designed to better organize information in submissions for scientific review.
February 25, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
What issues are hindering AI's utility in radiology?
By Erik L. Ridley
Artificial intelligence (AI) technology has much potential in radiology, but several key issues are limiting its current clinical utility, according to a presentation on Tuesday at a public workshop held by the U.S. Food and Drug Administration on the evolving role of AI in radiology.
February 25, 2020
2019 11 14 18 07 2163 Computer Doctor Future 400
Abbott recalls 2 coronary angioplasty catheters
By AuntMinnie.com staff writers
Pharmaceutical and healthcare company Abbott Laboratories has issued a voluntary recall of specific lots of two of its catheters used in coronary angioplasty procedures.
February 24, 2020
2020 02 25 18 49 3356 Abbott Aacc 2019 400
FDA clears KinetiCor's MRI motion correction system
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared KinetiCor's MRI optical motion correction system for use with Siemens Healthineers' Magnetom Skyra 3-tesla scanner.
February 23, 2020
2020 02 24 17 44 7728 Clearance Stamp 400
Va. mammography center gets certificate reinstated
By AuntMinnie.com staff writers
A mammography center in Virginia is once again practicing diagnostic imaging after its accreditation and certificate had been suspended for serious image quality problems.
February 19, 2020
2020 02 20 00 48 1332 Approved Stamp 400
Radiological societies lobby against NIH cuts
By AuntMinnie.com staff writers
A group of 335 professional medical societies -- including 24 radiological and imaging organizations -- is urging Congress to increase rather than decrease funding to the U.S. National Institutes of Health (NIH) in 2021.
February 16, 2020
2018 05 18 21 49 2692 Gov Money 400
FDA seeks help to prevent vaping-related lung injuries
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a public call for more information to help prevent future vaping-related injuries. The agency is asking for information on substances used by vapers and ways to make vaping products tamper-proof.
February 16, 2020
2016 09 02 09 36 05 93 Fda Logo V2 400
Fla. practice cited for serious image quality problems
By AuntMinnie.com staff writers
A Florida ob/gyn practice cited for performing mammography without an active certificate has warned patients about serious problems with image quality, according to a new adverse event report from the U.S. Food and Drug Administration.
February 11, 2020
2019 10 07 17 39 4512 Warning Circular 400
FDA reinstates Raleigh Radiology's accreditation
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) on February 11 announced that it had reinstated accreditation for a facility in Raleigh, NC, that had experienced mammography technical quality issues.
February 11, 2020
2016 04 11 16 41 58 174 Approved Stamp 200
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