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.   

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. 

AI cardiology heart artificial intelligence deep learning

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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McLaren confirms it was hit with ransomware; disruptions to last until September

The Michigan-based health system is not sure what data may have been taken during the breach. An investigation is ongoing.

healthcare business deal

Edwards continues valve-focused M&A streak by acquiring promising TAVR startup

The move makes it crystal clear that Edwards remains focused on pursuing advanced TAVR technologies. The company just acquired JenaValve, another company dedicated to developing new AR treatments, back in July.

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Reduce, reuse, recycle: How cath labs can lower cardiology’s colossal carbon footprint

Cath labs, like radiology suites and operating rooms, are leading contributors to the world’s growing carbon footprint.

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Q&A: Tips to thrive as an independent practice in the age of consolidation

An interview with Rik Baier, CMPE, Chief Executive Officer of Barrington Orthopedic Specialists and the Schaumburg Surgery Center, on the struggle of maintaining practice autonomy.

Around the web

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. 

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%. 

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.