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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Industry concerns over paclitaxel-coated devices may have put PAD patients at risk

Back in 2019, the FDA issued a warning about the use of paclitaxel-coated devices when treating peripheral artery disease. The agency took back that warning in 2023, but it appears to have made a significant impact on patient care. 

FDA Commissioner Robert Califf, MD, explains the U.S. is spending the most on healthcare of any country, but has poorer outcomes than other western nations. He said healthcare reform is needed to change that course. #Healthdisparities #healthequity

FDA commissioner urges health systems to strengthen AI quality oversight

FDA Commissioner Robert Califf, MD, explains the need for hospitals to perform quality assurance checks on clinical artificial intelligence to ensure these technologies don't "drift" from what was originally cleared by the FDA.
 

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Cardiologists to highlight the many benefits of AI-powered CCTA evaluations

Two renowned cardiologists are teaming up to explore the short- and long-term impact of using advanced AI platforms to evaluate coronary CCTA results for signs of coronary artery disease. 

Artivion, an Atlanta-based medical device company, has received a Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for its AMDS Hybrid Prosthesis designed to treat DeBakey Type 1 dissections when malperfusion occurs. This HDE ensures select patients can be treated with the device before the FDA makes its final approval decision.

First surgical device of its kind granted key FDA exemption

This update helps ensure Artivion's AMDS Hybrid Prosthesis can be used to treat high-risk patients as the FDA makes its final approval decision. The news came as Artivion works to bounce back from a cybersecurity attack that occurred in November.

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Interventional cardiology’s first Match Day celebrated as a ‘historic achievement’

This was a moment years in the making for interventional cardiology. A total of 164 training programs participated, and 94% of applicants secured a position. 

FDA approves new short-term treatment for AFib, atrial flutter in critical care settings

Landiolol, sold by AOP Health under the brand name Rapiblyk, is an intravenous treatment designed to start working right away.

pharmaceutical drug approval process

FDA approves acoramidis, BridgeBio’s new ATTR-CM drug

Acoramidis, a selective transthyretin stabilizer being sold under the brand name Attruby, is now the second ATTR-CM medication to gain FDA approval.

Medtronic has received U.S. Food and Drug Administration (FDA) clearance for its new InPen smartphone app and announced the launch of its new Smart MDI system. Smart MDI was designed to provide real-time insights for users on multiple daily injection (MDI) therapy. It includes the InPen smart insulin pen, the InPen app and Medtronic’s disposable, all-in-one Simplera continuous glucose monitor (CGM), which received U.S. Food and Drug Administration approval back in August.

Medtronic receives key FDA clearance, launches new diabetes system

Medtronic designed its new Smart MDI system to provide real-time insights to users on multiple daily injection therapy.

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Around the web

Radiology Business
Key takeaways from RSNA 2024 for AI, CT, MRI and the radiology staffing shortage

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

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.