Regulatory: Page 20

FDA commissioner Hahn leaves agency

By Brian Casey

Dr. Stephen Hahn, the commissioner of the U.S. Food and Drug Administration (FDA), has left the agency. He is being replaced on an interim basis by longtime FDA regulator Dr. Janet Woodcock.

January 19, 2021

Seno gets FDA nod for breast optoacoustic ultrasound

By AuntMinnie.com staff writers

Optoacoustic imaging firm Seno Medical Instruments has garnered U.S. Food and Drug Administration (FDA) premarket approval for its Imagio breast imaging optoacoustic ultrasound system.

January 18, 2021

FDA proposal to relax 510(k) rules on AI raises eyebrows

By Brian Casey

A proposal by the U.S. Food and Drug Administration (FDA) to eliminate 510(k) review for a number of artificial intelligence (AI) software applications is raising eyebrows in the radiology industry. The question is whether the proposal will be implemented after the Trump administration ends this week.

January 18, 2021

CMS unveils final rule to speed up coverage of advanced tech

By Rebekah Moan

The U.S. Centers for Medicare and Medicaid Services (CMS) has issued a final rule designed to speed up Medicare coverage of innovative devices that have undergone prioritized regulatory review.

January 18, 2021

CMS streamlines prior authorizations in final rule

By AuntMinnie.com staff writers

The U.S. Centers for Medicare and Medicaid Services (CMS) has issued a final rule that allows certain payors, providers, and patients to have electronic access to pending and active prior authorization decisions. The move will result in fewer repeated requests for prior authorizations and reduce costs, CMS said.

January 17, 2021

IAEA launches project on software dosimetry

By AuntMinnie.com staff writers

The International Atomic Energy Agency (IAEA) has launched a project to investigate the use of software to assist radiology professionals with performing quality assurance and dosimetry on x-ray equipment.

January 15, 2021

NCRP nixes gonadal screening, urges regulatory changes

By Emily Hayes

The National Council on Radiation Protection and Measurements (NCRP) on January 13 advised against the routine use of gonadal shielding during abdominal and pelvic radiography. The change is in line with current scientific thinking on the risks of shielding, such as missed findings.

January 13, 2021

Lantheus submits drug master file for imaging biomarker

By AuntMinnie.com staff writers

Lantheus Holdings, parent company of Lantheus Medical Imaging, said that it has filed a drug master file with the U.S. Food and Drug Administration for NM-01, a PD-L1 imaging biomarker for use in nuclear medicine.

January 11, 2021

FDA publishes action plan for medical AI software

By Erik L. Ridley

The U.S. Food and Drug Administration (FDA) has published an action plan for medical artificial intelligence (AI) algorithms that includes a draft guidance, efforts to harmonize good machine-learning practices, and development of methodologies for evaluating algorithms and monitoring their real-world performance.

January 11, 2021

Coding changes that will impact radiology in 2021

By Erin Stephens

The big news in revisions to Current Procedural Terminology codes for 2021 is the overhaul of the evaluation and management section. Erin Stephens of Healthcare Administrative Partners explains.

January 7, 2021

Accuray nets FDA nod for ClearRT imaging technology

By AuntMinnie.com staff writers

Radiation oncology firm Accuray has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for its ClearRT helical kilovoltage CT imaging technology.

January 4, 2021

Trump signs spending bill with radiology payment changes

By Brian Casey

President Donald Trump on December 27 signed a massive federal spending bill that includes a number of changes to reimbursement for radiology and radiation therapy procedures. Trump's move resolves questions about whether the bill would become law after he questioned the size of COVID-19 aid payments.

December 27, 2020

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