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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The Teleflex Ringer Perfusion Balloon Catheter has been approved by the FDA for PCI.

FDA clears perfusion balloon catheter for complex PCI cases

The newly cleared device includes a rapid-exchange catheter and a helical balloon that takes the shape of a hollow cylinder when inflated.

AMA survey: Prior authorization causes many patients to abandon care, raises healthcare costs

Prior authorization is frustrating to clinicians, but a new survey from the American Medical Association shows it also frustrates patients to the point of abandoning care. The survey showed many more insights regarding PA impact on care.

doctor looking at CLTI patient's leg

FDA clears medical device company’s full line of vascular testing systems

The newly cleared devices are all designed to detect signs of PAD and/or PVD early enough that limb amputation is not required. 

Elixir Medical DynamX sirolimus-eluting coronary bioadaptor FDA

FDA grants drug-eluting bioadaptor its breakthrough device designation

The Elixir Medical DynamX sirolimus-eluting coronary bioadaptor is designed to improve coronary luminal diameter, help restore hemodynamic modulation and reduce plaque progression in patients with de novo coronary artery lesions.

Medicare money payment physician

Cardiology groups push for Medicare reform in face of ‘unsustainable’ payment cuts

Nearly 130 healthcare groups are urging Congress to pass legislation that would provide relief to U.S. physicians struggling to keep up with wave after wave of payment reductions.

Restore Medical ContraBand medical device heart failure

FDA grants new heart failure implant its breakthrough device designation

Restore Medical's ContraBand system was designed to address symptoms in HFrEF patients who do not respond to other therapies. 

The American Society of Nuclear Cardiology (ASNC) is asking Congress to repeal the appropriate use software provision mandate, which physicians say is an obstacle to efficient care.

ASNC asks Congress to officially repeal the AUC mandate for advanced medical imaging

Medicare rescinded the provision in the 2024 Medicare Physician Fee Schedule, but the law remains on the books. 

Cordis has received U.S. Food and Drug Administration (FDA) approval for its new MYNX Control Venous Vascular Closure Device (VCD) for 6F-12F access sites. The company hopes to launch the newly approved extravascular closure device in the months ahead.

Cordis gains FDA approval for new closure device, inks pricing deal with Premier

The newly approved extravascular closure device was designed for procedures with access sites from 6 to 12 French. It uses the same proprietary GRIP technology found in other Cordis interventional devices.

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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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