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. 

CMS changes coverage policy for carotid stenting to make it more widely available

A group of interventional cardiologists, neurologists and vascular surgeons successfully petitioned Medicare to change its coverage determination for carotid stenting procedures.

M&A mergers and acquisitions business deal

FTC wants to hear from physicians about their experiences with private equity

Chair Lina M. Khan spoke about the topic during the closing keynote at the American College of Emergency Physicians’ annual meeting in Philadelphia.

artificial intelligence money finance acquisition

Number of FDA-cleared AI imaging tools expected to skyrocket by 2035, backed by $30B in funding

During the past seven years, the availability of such products has continued to grow, with medical imaging accounting for 85% of digital health’s venture capital funding.

lung cancer screening

Radiology experts score $4.6M grant to develop liquid biopsy technology for early lung cancer detection

“The goal is to create a blood test that can be used in clinics to complement CT imaging assessment of lung nodules for cancer risk," UCLA radiologist Denise Aberle noted. 

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CMS removes national coverage determination for beta-amyloid PET, expanding access to vital imaging exam

Eliminating the previous “coverage with evidence development” requirement allows local MACs to dictate payment for such exams. 

Medtronic's Evolut FX TAVR valve, designed with 3 golden markers that improve alignment

Medtronic receives CE mark approval for Evolut FX TAVR system

The self-expanding valve, already approved by the FDA, was designed with three gold markers to boost implanter efficiency, an updated catheter tip and a more flexible delivery system.

COVID-19 congress coronavirus Washington

American College of Radiology urges Congress to address ‘worsening’ physician shortages

Of the nearly 21,000 radiologists engaged in active patient care, 53% are age 55 or older, the college's EVP told lawmakers. 

Impella Heart Pump Abiomed RECOVER IV RCT cardiogenic shock

FDA warns Abiomed about ‘significant violations’ related to its Impella heart pumps

The agency said Abiomed did not seek the necessary approvals for one Impella-related device and was slow to act on certain safety concerns.