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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Ancora Heart AccuCinch Ventricular Restoration System heart failure FDA

Regulatory Roundup: FDA clears AI-powered Apple Watch competitor, grants breakthrough designation to new heart failure device

Ancora Heart received the FDA’s breakthrough device designation for its AccuCinch Ventricular Restoration System, a new minimally invasive transcatheter device designed for the treatment of heart failure.

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Amazon’s $4B takeover of One Medical is already under fire

Within hours of Amazon announcing its intention to acquire healthcare provider One Medical for $3.9 billion in cash, lawmakers took aim at the retail giant to pursue blocking the deal.

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Providers ask for higher payments in OPPS proposed rule

The proposed payment increase of 2.7% doesn't make up for sequestration cuts, inflation, and other factors hitting hospitals, medical groups say. 

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Autoimmune patients caught in crossfire of Supreme Court's Roe decision

Some patients with certain autoimmune diseases are finding it difficult to obtain their prescriptions for methotrexate as a result of changing abortion care laws.

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Abortion care still protected in emergency situations for all Americans, Biden administration clarifies

The Biden administration has seemingly found a way to federally protect abortion care services in all states in some circumstances.

Medtronic recalls more than 1M dialysis catheters

This is a Class I recall, which means using the devices could cause "serious adverse health consequences or death."

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FDA to consider OTC birth control application

The application comes just weeks after the Supreme Court overturned Roe v. Wade, which guaranteed the right to abortion care in the U.S. for nearly 50 years.

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Theranos exec found guilty on 12 counts of fraud, conspiracy

The chief operating officer of the now defunct blood-testing company was found guilty of 12 counts of wire fraud and conspiracy. 

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Around the web

Cardiovascular Business
Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

Cardiovascular Business
FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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