Regulatory: Page 18

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
2020 07 15 19 43 0222 Fda Sign Dc 400
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
2021 04 29 16 55 9257 Fist Cash 400
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
2019 02 13 19 24 5396 Fda Logo V2 400
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
2019 09 17 16 01 9179 Accuray Astro 2019
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
2020 02 24 17 44 7728 Clearance Stamp 400
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
2021 03 17 23 48 7787 Computer Ai Hud Display 400
Intelligent Ultrasound secures CE Mark for ScanNav Anatomy
By AuntMinnie.com staff writers
Ultrasound artificial intelligence and simulation software developer Intelligent Ultrasound Group has received the CE Mark for its ScanNav Anatomy: Peripheral Nerve Block software.
April 14, 2021
2021 03 11 21 54 5662 Computer Ai Artificial Illustration 400
Perimeter receives FDA breakthrough nod for AI software
By AuntMinnie.com staff writers
Perimeter Medical Imaging AI announced it has received the U.S. Food and Drug Administration (FDA) breakthrough device designation for its optical coherence tomography technology coupled with its ImgAssist artificial intelligence (AI) software.
April 14, 2021
2019 10 21 17 41 6509 Artificial Intelligence Ai Suit 400
U.S. House passes legislation to delay Medicare payment cuts
By AuntMinnie.com staff writers
The U.S. House of Representatives on April 13 passed a bill that would delay a 2% cut to Medicare provider payments through the end of 2021, according to a report from the Hill.
April 13, 2021
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Reps. ask CMS to change policy on radiopharmaceuticals
By AuntMinnie.com staff writers
Two members of the U.S. House of Representatives have asked the U.S. Centers for Medicare and Medicaid Services (CMS) to change what they said was a fundamentally flawed policy of reimbursing diagnostic radiopharmaceuticals as ancillary supplies for procedures.
April 13, 2021
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KA lands Health Canada license for Sight detector
By AuntMinnie.com staff writers
Digital x-ray manufacturer KA Imaging has garnered a medical device license from Health Canada for its Sight flat-panel detector.
April 12, 2021
2020 02 24 17 44 7728 Clearance Stamp 400
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