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 receives updated FDA approval for redo TAVR
The company also launched a new clinical trial designed to follow redo TAVR patients who present with symptomatic bioprosthetic valve failure for up to five years.
CDC director, chief medical officer ousted as RFK shakes up agency
CDC Director Susan Monarez, PhD, was less than a month into her role, having been confirmed by the U.S. Senate on July 30. Her lawyers said the staffing shakeup was a result of HHS Secretary Robert F. Kennedy Jr. “weaponizing public health for political gain.”
Under-reimbursement keeping radiologists from using key imaging modality, docs warn CMS
Radiologists and other physicians recently wrote to Administrator Mehmet Oz, MD, asking for changes related to contrast-enhanced ultrasound.
FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death
This latest alert was put in place after Johnson & Johnson MedTech learned that some of its Automated Impella Controllers were built to the wrong specifications, impacting their ability to function. Affected devices should not be used going forward.
Lowest dose gadolinium-based contrast agent to date inches closer to FDA approval
Gadoquatrane is now set to go through the regulatory review process on its trek to earning full FDA approval.

cybersecurity hacker ransomware cyber data breach

Biopharma company confirms ransomware attack as 176 GB data trove is posted

Indiana-based Inotiv confirmed the data breach in a filing with the U.S. Securities and Exchange Commission. Infamous cybercrime cell Qilin has claimed credit for the attack.

The U.S. Food and Drug Administration (FDA) updated the Breakthrough Device Program designations data this week, which now includes 1,176 Breakthrough Device designations, of which 160 have gained market clearance. Cardiovascular devices lead these with 243 devices, the highest number out of all other clinical categories. This includes 16 new cardiovascular devices cleared in the past year.

Cardiovascular device approvals continue to lead the FDA's Breakthrough Device Program

Cardiology is number one in FDA Breakthrough Device designations at 218, the highest number out of all other clinical categories. This includes 16 new devices cleared in the past year.

FTC challenge to Edwards JenaValve acquisition could delay FDA approval

Edwards Lifesciences asked the U.S. Federal Trade Commission (FTC) this week to dismiss the complaint against the company's acquisition of JenaValve this week. A healthcare market analysis firm also said the FTC actions will likely impact the timing of an FDA clearance of the Trilogy heart valve.

Healthcare AI today: Cancer research rethought, Trump/Kennedy healthcare AI, ‘What’s best for the patient?’

A new generation of AI-native researchers is leading the way in the war on cancer. This next crop of scientists is AI-native, interdisciplinary—and comfortable challenging assumptions.

Statue of Liberty New York City healthcare

NUMC accuses ex-CEO of deleting records, seeks $10M in damages

The New York-based safety net hospital has accused former CEO Megan Ryan of impropriety that includes paying out $3.5 million to herself and 12 other executives. She denies the allegations, and claims she is a whistleblower for fraud committed by the state.

FDA clears new trial of first-in-class treatment for pulmonary arterial hypertension

The new drug, VTB-10, previously received the FDA's orphan drug designation in 2024.

Tandem Diabetes Care is recalling a recent update of the mobile app for its t:slim X2 insulin pump due to repeated software issues that may cause the pump to shut down unexpectedly. The FDA has said this is a Class I recall.

Insulin pump error linked to 700 adverse events

Speaker issues are causing the devices to stop communicating with the user's CGM. Dozens of patient injuries have been reported, and the company is prepping a software update.

FDA hits pause on novel radiation therapy's approval

The therapy previously earned the FDA’s Breakthrough Device Designation due to its potential to treat certain cancers.

Policy & Regulations

Medtronic receives updated FDA approval for redo TAVR

CDC director, chief medical officer ousted as RFK shakes up agency

Under-reimbursement keeping radiologists from using key imaging modality, docs warn CMS

FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death

Lowest dose gadolinium-based contrast agent to date inches closer to FDA approval