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. 

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.

Abbott Volt Pulsed Field Ablation

Abbott PFA system gains FDA approval

The Volt Pulsed Field Ablation System from Abbott has been approved by the FDA. The technology, which gained CE mark approval in March, features a one-of-a-kind catheter design and allows patients to be treated under conscious sedation.

artificial intelligence money finance acquisition

HHS seeks input on how reimbursement, regulation could bolster use of healthcare AI

The key agency released a request for information on Dec. 19, asking for broad input on how it can accelerate the adoption of AI in clinical care. 

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New iron-based imaging agent significantly improves brain tumor visualization

Ferumoxytol is used primarily in medications that treat anemia, but the FDA recently cleared it for deployment in brain imaging as well.

Department of Justice DOJ

Grand jury indicts telehealth provider in alleged $100M Adderall distribution scheme

The U.S. Department of Justice has formally accused Done Global of unlawfully distributing ADHD medications without medical need, using a subscription program and targeted advertising to find patients searching for drugs. The company is also accused of filing false medical claims to Medicare, Medicaid and commercial insurance. Done's founder and CEO was convicted last month on related charges and awaits sentencing. 

HeartFlow Plaque Analysis

Cardiology’s biggest trend: New scientific statements take on AI-powered coronary plaque evaluations

The ACC and AHA both issued new statements on noninvasive CCTA offerings that use advanced AI to evaluate patients with suspected CAD. These technologies have gained significant momentum in recent years, and experts agree that they represent a game-changing advancement in the world of cardiovascular imaging.