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Medicare and FDA propose granting rapid coverage for breakthrough radiology devices

The two agencies on April 23 announced the rollout of the Regulatory Alignment for Predictable and Immediate Device, or RAPID, coverage pathway.

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Radiology groups endorse bill to exempt physicians from $100,000 visa fee

ACR, ASNR and over 40 other organizations shared their support for the Healthcare Workforce Act in a letter to lawmakers written April 15.

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AI not 'economically viable' if it doesn't replace at least some radiologists, experts claim

“Ignoring the economic drivers of automation will not prevent workforce transformation; it will only reduce our ability to shape it."

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Second phase of trial testing GE HealthCare's GBCA alternative gets underway

The imaging agent was recently granted the U.S. Food and Drug Administration’s Fast Track designation, as early clinical testing has been promising.

'Sterility failures' prompt FDA to threaten radiopharmaceutical producer with disciplinary action

Multiple issues that could raise the risk of product contamination were discovered during an inspection, according to an FDA warning letter.

How long will we accept patients languishing in the ER as normal? (asks a firsthand witness to ‘boarding’ who’s also a distinguished journalist and an erstwhile ER doctor)

Boarding is hospital-speak for when patients get left in the emergency department, typically on gurneys or in wheelchairs, for many hours—sometimes days—because no inpatient beds are available.

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Users on a Discord chat are playing with Mythos, an AI deemed too dangerous for the public

Developer Anthropic released the tool to a small number of organizations in hopes they can find security vulnerabilities. Now, a report reveals that a group of people on the popular Discord chat app have gained access. Mythos could be used as a powerful cybersecurity weapon.

FDA, CMS unveil rapid Medicare coverage pathway for critical medical devices

Prior to the new “RAPID” program announced on Thursday, it could take a year or more for Breakthrough-designated medical devices to earn approval for Medicare coverage. Now regulators say that timeline could be reduced to as little as two months.

Cardiologist sues health system over gender discrimination, unequal pay and hostile treatment

The veteran doctor says she was treated “vastly different from her male counterparts” during her 17 years with Lehigh Valley Health Network.

Chemical alterations in the brain hint at whether loss of smell will return post-COVID

Researchers have identified what they believe could serve as imaging biomarkers that predict recovery from anosmia after contracting the virus.

AI needle-path generation slashes insertions times for CT-guided biopsies

The technology offers measurable benefits without sacrificing insertion accuracy, according to new research.

Meril Life Sciences, an India-based medical device company founded in 2006, developed the Myval TAVR valve

Early outcomes with Myval TAVR valve comparable to popular devices from Medtronic, Edwards

Meril Life Sciences has been manufacturing its Myval heart valves for years. The devices are approved and available in both India and Europe, but they have not been approved by the FDA.

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Radiology Business

Medicare and FDA propose granting rapid coverage for breakthrough radiology devices

The two agencies on April 23 announced the rollout of the Regulatory Alignment for Predictable and Immediate Device, or RAPID, coverage pathway.