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. 

CVRx Barostim illustration

CMS increases inpatient payment for implantable Barostim device

CVRx has now received improved outpatient and inpatient reimbursements for its implantable heart failure device in the last 12 months. The company's president says these updates will help more patients gain access to the Barostim technology. 

Bharath Krishnamurthy, a director of Health Policy and Analytics at the American Hospital Association (AHA), explains the financial impact of the growing healthcare staffing shortage.

Healthcare staffing shortages leading to financial instability

Bharath Krishnamurthy, a director of health policy and analytics at the American Hospital Association, explains the financial impact of current healthcare staffing shortages.

Novartis sues FDA over ‘unlawful’ approval of generic heart failure drug

The drugmaker argues that the FDA's recent approval of a generic version of Entresto should not be allowed for multiple reasons. Novartis sent multiple requests to the agency hoping to stop the approval, but the FDA denied each one. 

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

Abbott says some FreeStyle Libre 3 sensors need replacement—patients should discontinue use

The new medical device correction only includes a select number of devices. Abbott said they produce inaccurate readings, putting patient health at risk. 

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.

Around the web

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

 

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

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