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. 

Medtronic is once again recalling its HeartWare Ventricular Assist Device (HVAD) pump implant kit, a part of the company’s HeartWare HVAD system. This is a Class I recall, which means using the device can lead to serious injury or death. The new recall includes more than 1,600 devices distributed from October 2006 to June 2021.

FDA announces another recall of Medtronic HVAD pump implant kits—1 patient death reported

The recall includes more than 1,600 devices distributed from October 2006 to June 2021. Medtronic's HVAD system has already been associated with multiple issues, including a separate recall in 2021. 

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Pandemic’s hardest hit breast-care segment: Screening mammography

COVID-19 set back screening mammography further than any other category of breast care, dropping schedule adherence during infection peaks to 36% of pre-pandemic rates.

Healthcare CEOs urge Congress to act on gun violence

Among the CEOs who signed the letter are a handful of prominent healthcare leaders.

Novavax NVX-CoV2373 COVID-19 vaccine myocarditis

FDA committee backs Novavax's COVID-19 vaccine despite heart damage concerns

The committee's approval comes days after the FDA shared details on a small number of trial participants who developed myocarditis or pericarditis after receiving the vaccine.  

Homegrown business curriculum teaches new rads how to ‘think like an MBA’

Harvard researchers have piloted a curriculum for instructing radiology trainees in the business of modern medicine. The teaching team says its program is adaptable by any academic radiology operation.

mergers acquisitions puzzle M&A

HCA’s latest deals on pause by FTC

The news comes just after HCA Healthcare was hit with a second antitrust lawsuit for anticompetitive actions.

NRC petitioned by patient advocacy group to require reporting of extravasation

The group is advocating for the NRC to treat significant extravasations in the same manner as any other reportable medical event. 

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HCA Healthcare hit with lawsuit over monopoly allegations

HCA Healthcare was recently hit with its second antitrust lawsuit — this time from the city of Brevard, North Carolina, for allegedly engaging in anti-competitive schemes.