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. 

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.

October 17, 2023
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. 

October 16, 2023
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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. 

October 13, 2023
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.

October 13, 2023
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. 

October 13, 2023
High-risk percutaneous coronary intervention (PCI) with an Impella heart pump is associated with better outcomes, including a significantly higher survival rate, than high-risk PCI with an intra-aortic balloon pump (IABP), according to new findings published in the American Journal of Cardiology. 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. 

October 12, 2023
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Endotronix gains key approval from FDA, shares new heart failure data

The company can now begin the enrollment process for its PROACTIVE-HF 2 clinical trial, which will focus on treating patients with NYHA class II heart failure. 

October 11, 2023
physician money payments dollars

Mobile imaging provider to pay $85M for false claims stemming from alleged referral scheme

The alleged kickback scheme spanned nine years, with Cardiac Imaging Inc. paying physicians "excessive fees" to oversee PET scans, the DOJ said.

October 11, 2023