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.

Blood filtration company fined $5.7M, executive charged, for covering up patient deaths
The U.S. Department of Justice said ExThera cooperated with the investigation into a failure to file adverse event notices with the Food and Drug Administration after two cancer patients who used its blood filtration systems in Antigua died shortly after returning home. The California-based company’s former chief regulatory officer has agreed to plead guilty and could serve prison time.
Tenaya Therapeutics could earn up to $1.1B for new heart disease research
Tenaya Therapeutics and Alnylam Pharmaceuticals have agreed to collaborate on identifying potential new gene therapies for the treatment of cardiovascular disease. Tenaya will receive an upfront payment of $10 million, but stands to earn much more.
Cardiology now has more than 200 FDA-cleared AI algorithms
Cardiology is No. 2 behind radiology when it comes to FDA-cleared AI algorithms. Neurology, meanwhile, is a distant No. 3.
FDA shares details about reprocessed catheter recall
Back in February, the FDA expanded a recall of several reprocessed EP and ultrasound catheters due to a risk of contamination. The agency is now sharing additional information with the public.
High-sensitivity troponin protocol most successful at freestanding EDs
Freestanding EDs demonstrated meaningful operational advantages over hospitals when using an accelerated troponin pathway. This included earlier discharges for low-risk chest pain patients.

Novartis building massive new radioligand manufacturing facility as part of $23B investment in US

The 46,000 square foot Denton site will be the fifth Novartis has constructed stateside. The company expects it to be fully operational by 2028.

Vascular imaging at heart of $71M fraud scheme—DOJ announces prison sentences

The years-long scheme involved sending kickbacks to physicians who ordered unnecessary transcranial doppler exams. Two conspirators have now been sentenced to prison and ordered to pay substantial fines.

Matthew Summers, MD, FACC, program director for structural heart, Sentara Heart Hospital, Norfolk, Virginia, explains how his center used a new transcatheter aortic valve replacement (TAVR) 3D CT planning software to better identify patients who are at high risk of complications. The software also enables the heart team to test the best placement of various valves to create a procedure plan tailored for each patients unique anatomy.

3D software helps cardiologists plan ahead for TAVR complications

Serious complications are rare after TAVR, but they can be catastrophic or fatal when they do occur. The care team at Sentara Heart Hospital found that bringing in new 3D software made it much easier to plan ahead for such issues.

simulation of the conduction pathway relative to various cardiac structures.

FDA clears AI-powered platform that personalizes care during TAVR, cardiac pacing procedures

The newly cleared CARA System from Cara Medical was designed to help clinicians before and during a variety of cardiac procedures. It provides a personalized 3D map of the patient's cardiac conduction system and then overlays that map onto live fluoroscopic images.

FDA announces recall on infusion systems after software anomaly injures 2 patients

The recall has been designated as the most serious, Class I, but the issue can be remedied with a software update. The affected devices are Ivenix Large Volume Pumps manufactured by Fresenius Kabi.

Radiopharmaceutical targeted toward treatment-resistant cancer put on FDA's Fast Track

The treatment addresses cancers that express Nectin-4, a protein found in excess of 80% to 90% of urothelial cancer patients.

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]

PFO closure after thromboembolism linked to strong 20-year outcomes

Recurrent strokes and TIAs were rare, though bleeding events among women did stand out as a trend to watch going forward.

Excessive alcohol use increases risk of amputation in CLTI patients

Identifying patients with alcohol use disorder prior to treatment may help care teams plan ahead and anticipate potential complications.

Clinical

Blood filtration company fined $5.7M, executive charged, for covering up patient deaths

Tenaya Therapeutics could earn up to $1.1B for new heart disease research

Cardiology now has more than 200 FDA-cleared AI algorithms

FDA shares details about reprocessed catheter recall

High-sensitivity troponin protocol most successful at freestanding EDs