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 cardiologyheart failure, electrophysiologyhypertension, structural heart disease, use of pharmaceuticals, and COVID-19.   

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing. 

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FTC sues drug middlemen over insulin prices, puts others on notice

The FTC alleges that pharmacy benefit managers have set up a system where they get rich, while patients are forced to pay rising insulin costs. The agency also called out drug manufacturers such as Eli Lilly, Sanofi and Novo Nordisk, saying their own actions have raised serious concerns.

money business cash flow dollar

Merit Medical to purchase Cook Medical’s lead management portfolio for $210M

Two medical device companies have announced a transaction that could shake up the U.S. electrophysiology market. 

A heart team at King Faisal Specialist Hospital & Research Center (KFSHRC) in Riyadh, Saudi Arabia, made a bit of history, completing the world’s first fully robotic heart transplant. The procedure, which lasted roughly two and half hours, was performed on a 16-year-old patient with end-stage heart failure. One reason this patient was selected was the fact that he had specifically requested the heart team not open his chest.

Surgeons make history, perform world’s first fully robotic heart transplant

The procedure, which lasted roughly two and half hours, was performed on a 16-year-old patient with end-stage heart failure. 

The rapid rise of artificial intelligence (AI) has helped cardiologists, radiologists, nurses and other healthcare providers embrace precision medicine in a way that ensures more heart patients are receiving personalized care.

FDA clears AI platform for planning ahead of TAVR, other heart procedures

The cloud-based platform identifies and measures cardiac structures in CT scans.

cross market hospital mergers

Abiomed, Biosense Webster, Cerenovus now all known as Johnson & Johnson MedTech

These companies were already part of the Johnson & Johnson family, but they had still retained their previous brand names. Now, each one is officially going by Johnson & Johnson MedTech. 

Video interview with Pedro Martinez Clark, MD, an interventional cardiologist, who explains how he overcame some key health disparities in Miami to make sure minority patients in low-income neighborhoods could receive screenings and care for peripheral artery disease (PAD).

Miami cardiologist works to reach more PAD patients in low-income neighborhoods

Pedro Martinez-Clark, MD, an interventional cardiologist and founder of Amavita Heart and Vascular Health, explains the health disparities he encounters that block the delivery of care in certain parts of Miami.

Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system

Safety update: Sensor issue with Abbott CGMs ruled a Class I recall

The sensors of certain FreeStyle Libre 3 devices are producing inaccurate glucose readings and should not be used. Two patient injuries have been reported. Abbott first reported the problem in July. 

Around the web

When regulating AI-equipped medical devices, the FDA might take a page from the Department of Transportation’s playbook for overseeing AI-equipped vehicles. These run the gamut from assisting human drivers to fully taking the wheel. 

Kit Crancer, RBMA board member, speaks with Radiology Business about key legislative developments on the Hill that will affect the specialty. 

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.