Regulatory: Page 20

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

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

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

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

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

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

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

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

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

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

Nines wins FDA clearance for AI lung nodule measurement

By AuntMinnie.com staff writers

Teleradiology services provider Nines has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for NinesMeasure, a semiautomatic artificial intelligence (AI)-based application for measuring lung nodules on chest CT exams.

March 29, 2021

FDA issues mammography alert for Tenn. facility

By AuntMinnie.com staff writers

The U.S. Food and Drug Administration (FDA) said it's alerting patients who received mammograms at Tennessee Women's Care in Nashville, TN, on or after November 1, 2019, that there may be possible problems with the quality of their mammograms.

March 29, 2021

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