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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Viz.ai partners with Cleerly in the name of AI-based CCTA evaluations

The new partnership is focused on getting advanced AI algorithms into the hands of cardiologists.

Brittany Nicole Weber, MD, PhD, Brigham and Women's Hospital, explains the growing role of cardio-rheumatology clinics.

The growing role of cardio-rheumatology clinics

Cardio-rheumatology clinics use a heart team-like approach to enhance care for patients with chronic conditions such as lupus, psoriasis and rheumatoid arthritis. "It's not just about cardiology," the director of one clinic explains. "We work closely with rheumatologists, dermatologists and even primary care physicians to provide comprehensive care."

Insulet Corporation, a Massachusetts-based medical device company focused on diabetes technology, announced that its Omnipod 5 Automated Insulin Delivery System is now cleared by the U.S. Food and Drug Administration (FDA) to manage type 2 diabetes (T2D).

FDA clears first automated insulin pump for type 2 diabetes

Insulet's Omnipod 5 Automated Insulin Delivery System was already cleared to help patients manage type 1 diabetes. 

Medicare coverage for weight loss drug semaglutide could cost up to $145B per year

Medications that target obesity are not typically covered by Medicare. When the FDA approved semaglutide as a way to treat certain cardiovascular risks, however, CMS said Medicare coverage was on the table. 

The U.S. Food and Drug Administration (FDA) has announced that Defibtech, a Nihon Kohden company, is recalling its RMU-2000 ARM XR Chest Compression Device due to significant safety concerns. This is a Class I recall, which means the FDA believes using the device “may cause serious injury or death.”

Automated chest compression device recalled after patient death

Regulators emphasized that these devices should not be used due to significant safety risks. 

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FDA approves new AI-powered imaging software from Nanox subsidiary

According to Nanox.AI, previously known as Zebra Medical Vision, the updated software helps "bridge the divide between radiology and cardiology."

pharmaceutical drug approval process

Drugmaker to ‘challenge’ FDA after only receiving tentative approval for inhaled PAH treatment

An exclusivity agreement is stopping Liquidia Corporation from gaining full FDA approval of its new inhalation powder for pulmonary arterial hypertension. The company said it is disappointed with the agency's decision and plans to "take quick action."

V-Wave has gained considerable attention or its Ventura Interatrial Shunt System, a small implantable device designed to reduce pressure on the left atrium and the lungs in patients with heart failure with reduced ejection fraction (HFrEF). The Ventura device includes a nitinol hourglass-shaped frame that anchors to the patient’s fossa ovalis in a way that prevents migration or embolization. It is implanted via an interventional procedure with fluoroscopy and echocardiography guidance.

Johnson & Johnson to acquire heart failure specialists V-Wave for up to $1.7B

V-Wave has gained considerable attention for its Ventura Interatrial Shunt System, a small implantable device designed to reduce pressure on the left atrium and lungs of HFrEF patients.

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Around the web

AI in Healthcare
Healthcare AI regulation needs nuance, balance: Research review

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. 

Radiology Business
Pending radiology bills in Congress and predicting the Trump administration's impact on imaging

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

Cardiovascular Business
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.