Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

Attune Medical has been granted De Novo marketing authorization from the US Food and Drug Administration (FDA) for its ensoETM device to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.

Cooling device now approved by FDA to reduce risk of ablation-related esophageal injuries

Already approved for temperature management, the single-use ensoETM device is now cleared for another use: minimizing the risk of potentially fatal injuries to the patient's esophagus during radiofrequency ablation procedures. 

hospital sustainability joint commission

Is your hospital helping ‘decarbonize’ the planet? Here’s a chance to prove it

Hospitals will soon have an opportunity to get their climate-conservation efforts formally recognized by U.S. healthcare’s largest body for setting standards and awarding accreditations.

money gavel court lawsuit legal judge judgement

Investment firm sues ultrasound developer QT Imaging hoping to force completion of merger deal

GigCapital5 and the Novato, California-based ultrasound-maker first announced their intent to partner in December 2022, creating a company with combined value of $151M. 

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Hospital CEO files lawsuit after losing job over naked art exhibition

According to the former executive, he was barely involved in planning the offsite fundraiser. The hospital declined to comment. 

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ACR sees burden and little benefit from CMS’s plan to tackle ‘excessive radiation dose’

The American College of Radiology is "urgently" asking that the agency rename the measure, worried that it could be spreading misinformation.

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FDA clears and grants breakthrough status for radiology triage tool from Annalise.ai

The Sydney, Australia-based vendor said its solution enables both passive and active notifications for suspected obstructive hydrocephalus. 

quality

Radiology groups urge CMS to retool the flawed Merit-based Incentive Payment System

Leaders with ACR, the RBMA and Radiology Partners all have recently written about concerning aspects of the quality-focused Medicare payment program. 

FDA announces recall of Abbott neurostimulation devices after MRI-related issues lead to 73 injuries

The new recall, which includes more than 155,000 implantable pulse generators, is due to ongoing issues with the devices being unable to exit MRI mode and return to normal use.