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 commissioner claims Biden administration hid heart risks of COVID-19 vaccines from public
The allegation came days after an internal FDA memo linked the vaccines to the deaths of multiple children. A group of former FDA commissioners pushed back against the content of that memo.
Kaiser Permanente agrees to $46M settlement over data incident affecting 13.4M people
The managed care company does not admit to doing anything wrong. The data breach constituted its use of third-party tracking technology on its website, which shared data with Google, Microsoft, Twitter, Meta and others.
Plan to extend ACA tax credits finds bipartisan support in the House
The new proposal to extend expanded subsidies for health plans sold through the Affordable Care Act is being backed by 35 Republicans and Democrats—but as the New York Times points out, it will be hard for the bill to get a floor vote.
FDA clears new left-heart access system from Atraverse Medical
The Hotwire Transseptal Access System includes the Hotwire RF Generator and Hotwire RF Guidewire, giving electrophysiologists the tools they need for left-heart access.
$V-Wave has gained considerable attention or its Ventura Interatrial Shunt System, a small implantable device designed to reduce pressure on the left atrium and the lungs in patients with heart failure with reduced ejection fraction (HFrEF). The Ventura device includes a nitinol hourglass-shaped frame that anchors to the patient’s fossa ovalis in a way that prevents migration or embolization. It is implanted via an interventional procedure with fluoroscopy and echocardiography guidance.$
FDA panel votes against approving first-of-its-kind heart failure device
All 15 members of the FDA's Circulatory System Devices Panel agreed that more data is required to confirm the new device from Johnson & Johnson MedTech is effective. Will the agency agree with these recommendations? Only time will tell.

Lawmakers override governor’s veto of bill requiring insurers to cover all breast imaging

Oklahoma Gov. J. Kevin Stitt first issued the decision May 5, contending the measure would impose “costly insurance mandates on private health plans” that would raise premiums.

FDA authorizes 1st AI tool to predict 5-year breast cancer risk from routine mammograms

Clairity Breast analyzes screening mammograms and can detect “subtle imaging features” correlated with long-term risk, the Boston-based company notes.

RFK floats starting new medical journal for administration scientists

On a podcast with wellness guru Gary Brecka, HHS Secretary Robert F. Kennedy Jr. said major medical journals have succumbed to the corrupting influence of pharmaceutical companies, and he may ban scientists with the National Institutes of Health (NIH) from publishing in them.

Cigna, CVS sue to block Arkansas' PBM regulation

The newly signed law, known as Act 264, bans pharmacy benefit managers from owning pharmacies in the state. It's scheduled to go into effect beginning in 2026.

Surgeons in Houston have performed the world’s first successful human implant of BiVACOR’s Total Artificial Heart (TAH) technology. The procedure was completed July 9, 2024, at The Texas Heart Institute at Baylor St. Luke’s Medical Center. It was part of an early feasibility study (EFS) first approved by the U.S. Food and Drug Administration (FDA) back in December 2023.

FDA sees promise in new total artificial heart technology, granting it ‘breakthrough’ status

The device was built as a bridge to transplant for patients with end-stage heart failure. It is made of titanium and approximately the size of an adult’s fist.

FDA warns vendor over 'life threatening' risks related to X-ray device

The mobile radiography units have reportedly been linked to two incidents—a near-miss involving a patient and a crash into an X-ray control panel.

Symptom-detected breast cancers nearly 7 times more likely to be diagnosed at advanced stage

Advances in treatment are often credited with improving breast cancer outcomes, but new findings suggest the decrease in mortality may actually be due to improved screening initiatives.

Reflow Medical Spur Peripheral Retrievable Stent System

New-look peripheral stent with expandable spikes receives FDA’s de novo classification

California-based Reflow Medical gained the approval after submitting data from the DEEPER REVEAL clinical trial. The device was associated with a high success rate and improved outcomes in CLTI patients.

Policy & Regulations

FDA commissioner claims Biden administration hid heart risks of COVID-19 vaccines from public

Kaiser Permanente agrees to $46M settlement over data incident affecting 13.4M people

Plan to extend ACA tax credits finds bipartisan support in the House

FDA clears new left-heart access system from Atraverse Medical

FDA panel votes against approving first-of-its-kind heart failure device