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. 

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heart surgery cardiac surgeons

FDA finalizes Class I recall for Medtronic catheters

There is a risk that these catheters will fail to retain their shape during use, causing procedure delays and creating the risk of an adverse outcome. The FDA first warned users about the issue back in August.

FDA recall medical device recall product recall

FDA confirms new recall for Johnson & Johnson heart device over safety concerns

Three patient deaths have been linked to connectivity issues with these devices. The FDA has classified this as a Class I recall.

insurance insurer payment claim denial reimbursement prior authorization

Integrating prior authorization into clinical workflows cuts costs, speeds up decisions

This utilization management tactic disproportionately affects specialties such as diagnostic radiology, radiation oncology and cardiology. 

healthcare surprise billing statement payment

Insurers fudging payment estimates for radiology services under No Surprises Act

A new analysis claims the “benchmark” qualifying payment amount insurers calculate often “dramatically” understates the actual median in-network rates they are paying for in-network care.  

hospital patient in distress crying

Replaceable doctors, online-only doctors, Dr. Thomas Keane & more healthcare AI news in brief

Medical misdiagnoses account for almost 800,000 deaths and other serious harms every year. Meanwhile healthcare AI is roundly celebrated for its diagnostic prowess. Can’t it help cut out a couple hundred thousand of those horrible mistakes?

Medtronic’s MiniMed 780G automated insulin delivery system

Medtronic’s diabetes spin-off files for IPO

Make way for MiniMed! Medtronic's diabetes division has filed the necessary paperwork to go public. The company hopes to be traded on Nasdaq under the symbol MMED.

breast radiologist breast cancer mammography

North American imaging experts endorse new international breast biopsy guidelines

The group was recently asked to provide input on a new set of recommendations for image-guided biopsies of suspicious breast lesions—offering providers clarity on key clinical scenarios.

warning safety alert recall healthcare issue

Bleeding reversal agent pulled from market over FDA’s safety concerns

AstraZeneca has stopped selling Andexxa because randomized data suggested some patients may face an increased risk of certain adverse events. The company emphasized that it remains confident in the agent's abilities.

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