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. 

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Shockwave Medical, a Johnson & Johnson MedTech company, has officially launched its Shockwave E8 Peripheral IVL Catheter in the United States. Shockwave’s E8 catheter was designed specifically to treat patients with calcified femoropopliteal and below-the-knee (BTK) peripheral artery disease (PAD), including those diagnosed with complex chronic limb-threatening ischemia (CLTI).

Shockwave Medical launches new FDA-approved IVL catheter for PAD, CLTI

The new device, already cleared by the FDA, was designed to treat femoropopliteal and below-the-knee PAD. 

Biotronik has received U.S. Food and Drug Administration (FDA) approval to make its Solia S lead and Selectra 3D catheter available for a new indication: left bundle branch area pacing (LBBAP).

FDA approves Biotronik lead, catheter for left bundle branch area pacing

LBBAP is a relatively new alternative to biventricular pacing. The FDA's decision was based largely on data from the BIO-CONDUCT clinical trial.

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Lawyer: Immigration policy reforms would address healthcare staffing shortages

Kathleen Campbell Walker, JD, immigration practice group chair at the law firm Dickinson Wright, explains how outdated immigration policy is exacerbating the healthcare staffing shortage.
 

Time running out to comment on higher cardiac CT payments

Imaging experts have said the move could reshape the financial landscape for hospitals offering Cardiac CT services.

Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system

Safety update: Sensor issue with Abbott CGMs ruled a Class I recall

The sensors of certain FreeStyle Libre 3 devices are producing inaccurate glucose readings and should not be used. Two patient injuries have been reported. Abbott first reported the problem in July. 

Renata Medical, a California-based healthcare technology company, has gained U.S. Food and Drug Administration (FDA) approval for a new stent specifically designed for pediatric patients with congenital heart defects. The Minima Growth Stent was built to treat newborns, infants and young children, and then it continues to expand as the patient ages

FDA approves new expanding stent for young children

The new interventional device from Renata Medical is designed to expand as young patients age, providing long-term relief. 

Insulet Corporation, a Massachusetts-based medical device company focused on diabetes technology, announced that its Omnipod 5 Automated Insulin Delivery System is now cleared by the U.S. Food and Drug Administration (FDA) to manage type 2 diabetes (T2D).

FDA clears first automated insulin pump for type 2 diabetes

Insulet's Omnipod 5 Automated Insulin Delivery System was already cleared to help patients manage type 1 diabetes. 

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Cardiology groups share new AUC for cardiovascular imaging prior to noncardiac surgery

The new AUC document was designed to help care teams know when and how to perform imaging-based cardiovascular evaluations on patients undergoing nonemergent, noncardiac surgery.

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Around the web

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

 

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

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