News

Medtronic Evolut FX+ TAVR
World’s most populous country gains access to Medtronic’s newest TAVR valve

Medtronic developed the self-expanding Evolut FX+ TAVR system with improved coronary access in mind. The FDA-approved device has now officially launched in India. 

Joan Michaels, RN, director of the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Transcatheter Valve Therapies (TVT) and IMPACT congenital heart registries, said the addition of the ambulatory surgical center (ASC) registry comes at a time when hospitals are expanding structural heart programs and ASC's will likely play a growing role to help free up more hospital cath labs for the more complex cases.
New registry helps hospitals expand outpatient services for heart patients

The initiation of the ACC Ambulatory Surgical Center Registry comes at a time when hospitals are expanding their structural heart programs. The registry is providing valuable details about which patients should stay at the hospital and which can be treated in an outpatient setting.

blood pressure hypertension cuff
FDA highlights risks of evaluating blood pressure with unauthorized medical devices

The agency emphasized that many over-the-counter technologies marketed for this purpose have not been properly evaluated. 

healthcare AI regulation
Healthcare AI today: Another angle on AI regulation, move fast but don’t break things, WISeR in the real world, more

Getting healthcare AI to fulfill its destiny—can we call it that now?—will require ‘scenario-based’ consideration of every use case.

Dhruv Headshot
CIVIE CEO Previews Major Announcement: ‘We See AI Giving Radiologists Complete Control Over Their Work-Life Balance’

Many if not most healthcare AI vendors market tweaked versions of large language models developed by other, usually larger companies. The lack of originality isn’t just a superficial concern. It may burden adopting healthcare organizations with practical, clinical and even legal risks. For clients of the radiology technology company CIVIE, formerly known as Collaborative Imaging, those worries are soon to be things of the past. 

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Repeat imaging rates higher when scans are interpreted by nurse practitioners, physician assistants

The finding is based on an analysis of nearly 1.4 million office-based imaging claims, conducted by the Harvey L. Neiman Health Policy Institute.  

prior authorization claim deny denial insurance insurer payer Medicare Advantage
Members of Congress condemn Medicare model targeting ‘wasteful’ interventional radiology services

“It is not an exaggeration to say that the requirement of prior authorization for traditional Medicare services will kill seniors,” says Rep. Mark Pocan, D-Wis. 

womanconsultation.jpg
Referrers frequently failing to recommend patients for key interventional radiology procedure

An analysis of nearly 272,000 uterine fibroid healthcare encounters shows that only about 4% of women underwent uterine fibroid embolization, a minimally invasive IR treatment option. 

Abbott's Navitor TAVR valve
Abbott receives expanded approval for Navitor TAVR system

Abbott's TAVR valve now has CE mark approval for treating low-, intermediate- and high-risk patients who present with symptomatic severe aortic stenosis. The news comes as new data on the valve's safety and effectiveness were just published in JACC: Cardiovascular Interventions.

Recor Medical's Paradise Ultrasound Renal Denervation System
Recor Medical gains historic approval for its ultrasound RDN system

Recor Medical's Paradise Ultrasound Renal Denervation System is the first medical device approved for the treatment of hypertension in Japan. It first gained FDA approval back in 2023.

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FDA changes imaging recommendations for patients taking popular Alzheimer's drug

Leqembi (lecanemab) was approved by the FDA in 2023. It is an infusion drug that has been shown to reduce Alzheimer’s-related cognitive decline by up to 27%. 

GE HealthCare Vivid Pioneer cardiovascular ultrasound
GE HealthCare launches ‘ultra-premium’ Vivid Pioneer cardiovascular ultrasound system

The company describes Vivid Pioneer as its “most advanced, ultra-premium and adaptive cardiovascular ultrasound system yet.” It includes new and improved AI capabilities and a compact design that is still fully functional in tight workspaces. 

Around the web

Cardiovascular Business
World’s most populous country gains access to Medtronic’s newest TAVR valve

Medtronic developed the self-expanding Evolut FX+ TAVR system with improved coronary access in mind. The FDA-approved device has now officially launched in India. 

Cardiovascular Business
New registry helps hospitals expand outpatient services for heart patients

The initiation of the ACC Ambulatory Surgical Center Registry comes at a time when hospitals are expanding their structural heart programs. The registry is providing valuable details about which patients should stay at the hospital and which can be treated in an outpatient setting.

Cardiovascular Business
FDA highlights risks of evaluating blood pressure with unauthorized medical devices

The agency emphasized that many over-the-counter technologies marketed for this purpose have not been properly evaluated. 

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