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 issues Class I recall on newborn resuscitation devices

The recall impacts products from ROi, supplied by Mercury Medical. A defective spring can cause a controller to malfunction, resulting in poor ventilation. 

the words "FDA recall" on a board

FDA announces recall of endoscope sheaths after 26 injuries

While there have been no reported deaths, certain lots of Olympus single-use guide sheath kits are to be quarantined immediately. 

The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA

FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.

female physician male

Request for an American Board of Cardiovascular Medicine denied—cardiology groups ‘deeply disappointed’

The ACC, AHA, HFSA, HRS and SCAI all worked together to try and make the new board a reality. Though their proposal has been denied, the groups say they are not done fighting. 

nurse practitioner NP physician assistant x-ray nonphysician interpret

ACR pans federal idea to let nonphysicians read X-rays, citing ‘resounding backlash’

The college announced its opposition to the CDC's B Reader program exploring whether to let nurse practitioners and physician assistants read certain radiographs. 

Why cardiac CT adoption remains low among primary care providers

The rapid rise of CCTA represents one of cardiology’s biggest ongoing trends, but most primary care providers are still not embracing a CT-first strategy.

Thumbnail

Injuries trigger recall related to tables used during image-guided procedures

Users have identified risks related to patients falling from the Philips furniture products during transfer or position changes, the FDA said Friday. 

Federal Trade Comission FTC Sign logo

FTC inquiry pauses $615M healthcare staffing merger

The merger between Aya Healthcare and Cross Country Healthcare was finalized in December 2024 and was expected to close in the first half of this year. It's unclear what information the Federal Trade Commission requested from both companies.