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.

Cardiologist reinstated after being fired for role with CDC vaccine panel
A veteran cardiologist is back on the job as a pediatric cardiologist after reportedly being fired for his participation in a controversial CDC panel. His wife shared the update, saying they were "truly humbled" by everyone who came to his defense.
Drugmaker moves ahead with sublingual heart attack treatment after positive FDA meeting
Based on feedback from the FDA, Aspire Biopharma plans on completing a multicenter clinical trial and then seeking regulatory approval for its new high-dose sublingual aspirin therapy.
ChatGPT is penetrating healthcare with explosive might, a US state is trying human-less prescription refills—and more AI news not to miss
If you still think of large-language AI as a newish thing yet to catch on with healthcare consumers, think again.
FDA issues Class I recall on B. Braun microbore extensions due to risk of death
The extensions are used to supply patients with fluids and drugs through an IV line. Despite being labeled as having them, the devices do not contain an air-eliminating vent. Because there is a serious risk of air embolism associated with the error, the FDA has given this recall its most serious designation.
Stereotaxis gains FDA approval for new robotically navigated cardiac ablation catheter
This new-look RF ablation catheter moves through the use of computer-controlled magnets, providing electrophysiologists with improved maneuverability and precision.

Kirk Milhoan, MD, PhD, a veteran physician who was recently named the chair of the CDC’s Advisory Committee on Immunization Practices (ACIP), has reportedly been fired from his day-to-day role as a pediatric cardiologist.

Cardiologist reinstated after being fired for role with CDC vaccine panel

A veteran cardiologist is back on the job as a pediatric cardiologist after reportedly being fired for his participation in a controversial CDC panel. His wife shared the update, saying they were "truly humbled" by everyone who came to his defense.

Drugmaker moves ahead with sublingual heart attack treatment after positive FDA meeting

Based on feedback from the FDA, Aspire Biopharma plans on completing a multicenter clinical trial and then seeking regulatory approval for its new high-dose sublingual aspirin therapy.

ChatGPT is penetrating healthcare with explosive might, a US state is trying human-less prescription refills—and more AI news not to miss

If you still think of large-language AI as a newish thing yet to catch on with healthcare consumers, think again.

FDA issues Class I recall on B. Braun microbore extensions due to risk of death

The extensions are used to supply patients with fluids and drugs through an IV line. Despite being labeled as having them, the devices do not contain an air-eliminating vent. Because there is a serious risk of air embolism associated with the error, the FDA has given this recall its most serious designation.

Magic Magnetic Interventional Ablation Catheter

Stereotaxis gains FDA approval for new robotically navigated cardiac ablation catheter

This new-look RF ablation catheter moves through the use of computer-controlled magnets, providing electrophysiologists with improved maneuverability and precision.

FDA approves new stent for deep venous disease

According to Gore, the newly approved device was built with conformability, strength and fracture resistance in mind.

Is RFK Jr. really conducting an ‘assault on vaccines’? And more high-level news notes

The CDC has gone ahead and changed its recommendations for childhood immunizations. The gnashing of teeth has only just begun.

FDA recalls surgical packs due to risk of microbial contamination

Multiple lots of ophthalmic surgery packs manufactured by Alcon will need to be disposed of, due to an incomplete seal that could cause the sterile bandages and syringes inside to be compromised. Because of the serious health risk posed to patients, this recall has been designated Class I.