Regulatory: Page 22

AI Metrics wins FDA nod for liver biopsy software
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer AI Metrics has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for its Liver Surface Nodularity virtual liver biopsy software.
November 16, 2020
2019 05 29 19 22 3353 Liver Anatomy 400
Atlas urges Michigan to 'rise up' against COVID-19 rules
By Brian Casey
Neuroradiologist and White House COVID-19 adviser Dr. Scott Atlas is drawing criticism for statements he made on Twitter over the weekend urging Michigan residents to "rise up" against lockdown rules designed to prevent the spread of COVID-19 in the state.
November 15, 2020
2020 11 10 23 17 2552 3d Closeup Coronavirus 400
Axonics files PMA supplement for further MRI labeling
By AuntMinnie.com staff writers
Axonics Modulation Technologies has filed a premarket approval (PMA) supplement with the U.S. Food and Drug Administration to secure clearance for detachable extremity coil MRI conditional labeling for its implantable sacral neuromodulation device on 1.5-tesla and 3-tesla scanners.
October 28, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
USPSTF proposes lowering colon screening age to 45
By AuntMinnie.com staff writers
Colon cancer screening should begin at age 45 instead of 50, according to a draft proposal issued October 27 by the U.S. Preventive Services Task Force (USPSTF).
October 28, 2020
2020 10 28 23 49 6025 Colon Polyps 400
Siemens receives FDA clearance for Ysio X.pree
By AuntMinnie.com staff writers
Siemens Healthineers has garnered U.S. Food and Drug Administration (FDA) clearance for Ysio X.pree, the firm's new premium digital radiography system.
October 26, 2020
2020 06 18 23 18 8611 Siemens Ysio X pree 2 Thumbnail
FDA clears Aidoc's incidental PE AI algorithm
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer Aidoc has garnered U.S. Food and Drug Administration (FDA) clearance for its computer-assisted triage technology in flagging and notification of incidental pulmonary embolism (PE) on CT scans.
October 21, 2020
2020 10 21 15 11 6219 2020 10 21 Aidoc 20201021151520
Quantib wins FDA clearance for prostate MRI AI software
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer Quantib has garnered U.S. Food and Drug Administration (FDA) clearance for an AI application designed to assist radiologists in interpreting prostate MRI exams.
October 21, 2020
2020 10 21 01 09 2843 2020 10 21 Quantib 400
CMS to delay start of RO Model for radiation therapy
By Brian Casey
The radiation oncology community has cause for celebration as the U.S. Centers for Medicare and Medicaid Services (CMS) decided to postpone for six months the implementation of its Radiation Oncology (RO) Model, a controversial new method of paying for radiation therapy treatments.
October 20, 2020
2016 08 22 10 18 31 293 Money Belt Tighten 400
Ezra gets FDA clearance for prostate AI software
By AuntMinnie.com staff writers
Cancer screening startup Ezra has received U.S. Food and Drug Administration (FDA) clearance for Ezra Prostate AI, an artificial intelligence (AI)-based software application designed to help radiologists analyze and segment prostate MRI exams.
October 19, 2020
2020 10 20 18 29 1638 2020 10 20 Ezra 3 D Prostate Lesion Ai 20201020184140
Feedback on FDA's proposed AI rules had industry ties
By Erik L. Ridley
Nearly two-thirds of commenters on last year's proposed regulatory framework from the U.S. Food and Drug Administration (FDA) for continuously learning artificial intelligence (AI) algorithms had financial ties to industry, while an additional 29% had unclear ties, according to a study posted online October 14 in BMJ Open.
October 15, 2020
2019 10 21 17 41 6509 Artificial Intelligence Ai Suit 400
Federal provider relief programs are continuously changing
By Rebecca Farrington
The COVID-19 pandemic spawned many programs designed to assist medical practices. The terms and conditions of many of the various relief programs have changed since they were first introduced, and Rebecca Farrington of Healthcare Administrative Partners helps explain recent changes.
October 14, 2020
2020 07 31 22 16 0362 Dollar Money Coronavirus Mask 400
CMS announces new COVID-19 loan repayment terms
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has announced new terms for repaying COVID-19 Medicare loans.
October 7, 2020
2019 10 30 21 49 9027 Cms Building 400
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