Regulatory: Page 21

FDA releases final guidance on medical device safety for MRI
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has released final guidance on how facilities should assess the safety and compatibility of medical devices in the MRI suite and recommended format for MRI safety information in medical device labeling.
May 18, 2021
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CMS opens review of expanded CT lung screening reimbursement
By Brian Casey
CT lung cancer screening could see expanded Medicare reimbursement soon. The U.S. Centers for Medicare and Medicaid Services (CMS) on May 18 opened up a review of its reimbursement policies in response to recent changes expanding the number of individuals who are eligible to be screened.
May 17, 2021
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Ultrasound societies say 'no change' to contrast agent policy
By Amerigo Allegretto
No changes should be made to clinical guidelines on the use of ultrasound contrast agents in the wake of the U.S. Food and Drug Administration's recent statement on adverse reactions to contrast, according to statements made by a group of medical societies.
May 10, 2021
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Whiterabbit gets FDA nod for breast density AI software
By AuntMinnie.com staff writers
Women's imaging artificial intelligence (AI) startup Whiterabbit has garnered U.S. Food and Drug Administration (FDA) clearance for its WRDensity breast density analysis software.
May 10, 2021
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BWXT to manufacture Boston Scientific's TheraSphere glass microspheres
By AuntMinnie.com staff writers
Medical isotope and radiopharmaceutical supplier BWXT Medical has signed an agreement with Boston Scientific to manufacture that firm's TheraSphere yttrium-90 glass microspheres.
May 9, 2021
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FDA debuts online billing process for MQSA inspection fees
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) is going to begin collecting user fees online for annual inspections conducted under the Mammography Quality Standards Act (MQSA).
May 6, 2021
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ACR urges Congress to boost MPFS payments by $3B for 2022
By AuntMinnie.com staff writers
The American College of Radiology (ACR) has joined with 62 other organizations in urging the U.S. Congress to boost Medicare Physician Fee Schedule (MPFS) payments by $3 billion for 2022 to support the nation's further recovery from the COVID-19 pandemic.
April 28, 2021
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ACR: FDA issues warning on allergies to US contrast
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) is advising healthcare providers against administering ultrasound contrast agents to patients with known allergies to polyethylene glycol, according to an update by the American College of Radiology (ACR).
April 21, 2021
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Accuray to tap Japanese market for ClearRT
By AuntMinnie.com staff writers
Accuray has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare to sell its ClearRT helical fanbeam kVCT imaging system in Japan.
April 21, 2021
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DeepHealth gets FDA nod for AI mammo triage software
By AuntMinnie.com staff writers
Imaging service provider RadNet's DeepHealth artificial intelligence (AI) subsidiary has garnered U.S. Food and Drug Administration (FDA) clearance for its Saige-Q AI-based mammography triage software.
April 19, 2021
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Goodbye, PACS. Hello, MIMPS? FDA updates rules for radiology software
By Erik L. Ridley
The U.S. Food and Drug Administration (FDA) has amended the descriptions of eight classification regulations -- including three that are radiology-specific -- to reflect recent regulatory changes. Among the changes, the agency is retiring the use of PACS in favor of MIMPS, or medical image management and processing system.
April 15, 2021
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Biden administration nixes FDA plan to lift reviews of AI software
By Brian Casey
Saying the proposal was riddled with "errors" and "ambiguities," the Biden administration on April 16 torpedoed a plan proposed in the waning days of the Trump administration to eliminate 510(k) reviews for a range of medical products, including artificial intelligence (AI) software.
April 15, 2021
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