Regulatory: Page 13

Philips receives clearance for liver fat quantification tools
By AuntMinnie.com staff writers
Philips recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its liver fat quantification tools.
November 15, 2021
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Probe of COVID pandemic response puts Atlas back in news
By AuntMinnie.com staff writers
Controversial neuroradiologist Dr. Scott Atlas is back in the headlines. A subcommittee of the U.S. House of Representatives that's investigating the Trump administration's response to the COVID-19 pandemic criticized Atlas for what it said was his role in changing federal guidelines for COVID-19 testing.
November 14, 2021
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CMS officially kills 'breakthrough' medical device program
By AuntMinnie.com staff writers
It's official. The U.S. Centers for Medicare and Medicaid Services (CMS) has killed a Trump administration-era program to promote the development of "breakthrough" medical devices.
November 14, 2021
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Biden taps Califf to once again lead FDA as commissioner
By Brian Casey
It's back to the future at the U.S. Food and Drug Administration (FDA). President Joe Biden on November 12 tapped cardiologist Dr. Robert Califf to lead the agency as commissioner, a role he held from 2016-2017.
November 11, 2021
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HeartVista brings AI software to Siemens MRI scanners
By AuntMinnie.com staff writers
Cardiac MRI artificial intelligence (AI) software developer HeartVista has received U.S. Food and Drug Administration 510(k) clearance to market its One Click MRI acquisition software for MRI scanners from Siemens Healthineers.
November 9, 2021
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ACR sees benefits for radiology in the 2022 HOPPS rule
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services' on November 2 released its final rule for the 2022 Medicare Hospital Outpatient Prospective Payment System, and the American College of Radiology (ACR) sees some benefits for radiology.
November 3, 2021
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ICD-10 coding changes your radiology practice should know
What updates that affect radiology practices have been made to the International Classification of Diseases Clinical Modification (ICD-10-CM) coding system? We talked to Erin Stephens, client manager of education at Healthcare Administrative Partners, about the recent changes.
November 3, 2021
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Release of final Medicare payment rates raises ire of physician groups
By Brian Casey
A number of healthcare groups are protesting final rules on Medicare 2022 payment released late on November 2 by the U.S. Centers for Medicare and Medicare Services. The rules lock in a number of payment cuts for healthcare providers.
November 1, 2021
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Global regulators unveil initiative on development of safe AI
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA), Health Canada, and the U.K.'s Medicines and Healthcare products Regulatory Agency have jointly issued a list of guiding principles for developers of medical devices based on artificial intelligence (AI) and machine learning.
October 26, 2021
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NIH invests $75M to advance data science in Africa
By AuntMinnie.com staff writers
The U.S. National Institutes of Health (NIH) is investing $74.5 million over five years to advance data science and trigger health discoveries in Africa.
October 26, 2021
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Sofie submits IND application for pancreatic PET agent
By AuntMinnie.com staff writers
Molecular imaging developer Sofie Biosciences has submitted an investigational new drug application (IND) with the U.S. Food and Drug Administration for a radiopharmaceutical targeting the fibroblast activation protein inhibitor.
October 11, 2021
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Delphinus gets FDA nod for 3D whole-breast US system
By Amerigo Allegretto
The U.S. Food and Drug Administration (FDA) has approved Delphinus Medical Technologies' new 3D whole-breast ultrasound system for detecting cancer in women with dense breasts.
October 11, 2021
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