Clinical

This channel newsfeed includes clinical content on treating patients or the clinical implications in a variety of cardiac subspecialties and disease states. The channel includes news on cardiac surgery, interventional cardiology, heart failure, electrophysiology, hypertension, structural heart disease, use of pharmaceuticals, and COVID-19.   

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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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Insulet wins $452M in lawsuit against rivals over medical device trade secrets

Insulet accused multiple parties, including a rival CEO, of working together to copy its insulin pump technology and bring a "clone product" to market.

Acutus Medical, the California-based healthcare technology company focused on electrophysiology devices, has announced significant downsizing that will cut its workforce by approximately 70%. The goal of the move is to focus exclusively on manufacturing and distributing left-heart access devices as part of a distribution deal with Medtronic that was first signed in 2022.

Medical device company cuts 70% of staff in push to meet Medtronic obligations

California-based Acutus Medical has said its ongoing agreement to manufacture and distribute left-heart access devices for Medtronic is the company's only source of revenue. 

Anthem

Anthem BCBS reverses course on anesthesia time limits

After announcing it would place time limits on reimbursement for the time a patient is under anesthesia, Anthem Blue Cross Blue Shield has now denied it ever intended to make the change. 

FDA issues Class I recall on insulin syringes due to risk of death

A line of syringes manufactured by Cardinal Health may fail to properly inject insulin when used with needleless IV connectors. 

Robotic aortic valve replacement (RAVR) is a new minimally invasive treatment option for symptomatic severe aortic stenosis (AS) that uses advanced robotic surgical systems. It has already started gaining momentum as an alternative to both surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR).

Q&A: Pioneer heart surgeon on the development and long-term potential of robotic aortic valve replacement

It's early for RAVR, but the minimally invasive technique has already started gaining momentum as an alternative to both SAVR and TAVR. We spoke to Vinay Badhwar, MD, one of the world’s leading voices in robotic heart surgery, to learn more.

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Michigan doctor claims he was fired for reporting unnecessary pacemaker surgeries

Daniel West, MD, is suing Trinity Health Muskegon and seeking whistleblower protection after reporting alleged malpractice and being summarily terminated.

Charles E. Mullins, MD, a U.S. Army veteran known as a legend of interventional pediatric cardiology, died Nov. 17. He was 92 years old.

Charles E. Mullins remembered as a pioneer of interventional pediatric cardiology

Charles E. Mullins, MD, a U.S. Army veteran who went on to practice medicine for five decades, died at the age of 92. SCAI shared a loving tribute to Mullins, calling him the "father of modern interventional pediatric cardiology."

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Around the web

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Nat’l Academy of Medicine sets ‘priorities for action’ as healthcare mulls next moves with AI

Given the precarious excitement of the moment—or is it exciting precarity?—policymakers and healthcare leaders must set directives guiding not only what to do with AI but also when to do it. 

Cardiovascular Business
Biden chooses semaglutide for next round of Medicare price negotiations—Trump gets final say

The final list also included diabetes drugs sold by Boehringer Ingelheim and Merck. The first round of drug price negotiations reduced the Medicare prices for 10 popular drugs by up to 79%. 

AI in Healthcare
4 ways HHS plans to help shape a national strategy for healthcare AI

HHS has thought through the ways AI can and should become an integral part of healthcare, human services and public health. Last Friday—possibly just days ahead of seating a new secretary—the agency released a detailed plan for getting there from here.