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.

FDA approves nasal spray for edema associated with congestive heart failure
The newly approved intranasal loop diuretic can also be used to treat edema in patients with liver and kidney disease.
Cardiologists lead charge for medical device approvals in Europe to be more rigorous
There is a belief among some clinicians that it is too easy for companies to gain CE mark approval for their medical devices. However, a new proposal from the European Society of Cardiology and other groups could help change that.
Medline recalls surgical kits due to safety concern with Medtronic catheters
The FDA is warning the public that certain Medline surgical kits may contain catheters that have been linked to 41 customer complaints and three serious injuries.
11% of U.S. adults were uninsured in 2024, Census data shows
Newly released data from the U.S. Census Bureau shows most Americans still rely on work for their health coverage, with 53.8% of insured Americans receiving coverage through their employer.
MGMA: Ending ACA subsidies could strain health system, leave millions uninsured
Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains the political and patient care issues involved with ending Affordable Care Act subsidies.

How a newly secured 3D printing patent could stabilize radioisotope production

Recently, a patent for 3D printed uranium targets was secured by the National Center for Nuclear Research (NCBJ) in Swierk, Poland, and it could increase the production of Molybdenum-99 (Mo-99) globally.

Virtual reading room remains popular post-pandemic among certain radiologists, referrers

A large academic medical center launched a virtual radiology reading room in 2020 to comply with COVID-related social distancing guidelines. Today the room is still something of a hit.

FDA changes indications for Impella RP heart pump after dramatic shift in mortality rate

The Impella RP System is still associated with significant benefits, the FDA said, but there are certain high-risk patients who should no longer be eligible for treatment.

Integra LifeSciences to acquire SIA in deal worth up to $140M

Integra LifeSciences Holding Corporation, a global medical technology company, has agreed to acquire Surgical Innovation Associates (SIA), which is known as the manufacturer of monofilament mesh for plastic and reconstructive surgery. The deal is valued up to $140 million.

Medtronic reaches milestone in study of pulsed-field ablation and mapping catheter for AFib

A randomized study of more than 450 patients with persistent atrial fibrillation is now underway. All patients have been treated, and their outcomes will be tracked for 12 months.

Amazon’s $3.9B acquisition of One Medical under review in Oregon

The state of Oregon is taking a hard look at the proposed acquisition of One Medical by Amazon. The deal is valued at $3.9 billion.

As FDA approaches decision on Alzheimer's drug, 2 deaths raise concerns

Japanese pharmaceutical company Eisai has denied that two deaths that have sparked concerns about a new Alzheimer's disease drug treatment are attributed to its trials.

FDA announces another recall for troubled heart device after multiple hospitalizations

This latest recall involves the device's driveline boot cover, which “can become stiff over time” and cause problems for clinicians. There have been 33 complaints since 2017 related to the issue.

Policy & Regulations

FDA approves nasal spray for edema associated with congestive heart failure

Cardiologists lead charge for medical device approvals in Europe to be more rigorous

Medline recalls surgical kits due to safety concern with Medtronic catheters

11% of U.S. adults were uninsured in 2024, Census data shows

MGMA: Ending ACA subsidies could strain health system, leave millions uninsured