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.

Sanitation issue forces FDA recall of ventilator suction systems
Ballard Closed Suction Systems will need to be returned to the manufacturer for a refund due to the high risk of a potentially fatal infection stemming from their use.
Myval TAVR valve associated with positive durability data after 4 years
Researchers have been spending more and more time evaluating the Myval TAVR valve from Indian medtech company Meril Life Sciences. The balloon-expandable device is available in some parts of the world, but not the United States.
Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation
CMS has finalized a new national coverage determination for T-TEER, sometimes known as transcatheter tricuspid valve repair. Abbott's TriClip is the only device approved by the FDA for T-TEER, but other treatment options are under development.
World’s first patient receives new-look heart pump—cardiologist ‘impressed’ by device’s performance
The CorWave technology is unlike other left ventricular assist devices, working in harmony with the patient's heartbeat and making adjustments as needed.
FDA issues Class I recall on infant heated wire circuits prone to disconnect
The faulty adapters must not be used. The devices, manufactured under the brand name AirLife, must be identified and quarantined because of the high risk of severe injury or death associated with the malfunction.

3 industry partnerships, 1 clinical aim: Enriching the global supply chain of medical isotopes

Nuclear medicine operations may soon enjoy steadier flows of certain in-demand radioisotopes. If so, much credit will go to companies that had the strategic sense to collaborate with each other.

Veterans Affairs denies it discriminates based on politics, marital status

A report from the Guardian details how the VA removed language protecting patients from discrimination based on political affiliation and lifestyle. The department denies that there has been any actual change in policy.

mergers and acquisitions M&A partnerships

Ascension buys ambulatory surgery centers in deal reportedly worth $3.9B

Nonprofit Ascension Health announced its purchase of Amsurg, adding 250 outpatient surgery centers to its expanding portfolio. The Catholic-based hospital group said the move will allow it to focus more on community-based care by keeping more patient referrals in-house.

Shoulder ultrasound effectively detects insulin resistance, even before abnormal labs

POCUS could represent a quick, easy and affordable way to detect signs of insulin resistance before it progresses into diabetes, researchers suggest.

Updated: Dexcom recalls more than 700K CGM receivers over safety issues—dozens of adverse events reported

There is an increased risk that these devices will not provide audible alerts for low or high blood glucose levels. The FDA has ruled that this is a Class I recall, highlighting the safety risks associated with missed alerts.

Medtronic technology at center of new hands-on training center for surgeons, interventionalists

The Pearl, a new innovation hub in North Carolina, will soon be home to the first training center of its kind. Many of the advanced technologies on hand will be designed by Medtronic.

SS Innovations International SSi Mantra 3 robotic surgery system

Robotic heart surgery represents a key step forward for SS Innovations

The company's SSi Mantra 3 robotic surgery system has already gained regulatory approvals in several countries. FDA approval is anticipated by late 2025 or early 2026.

Ivenix infusion kits recalled by FDA due to serious manufacturing defect

Lines included in the kits were misassembled and could result in a botched blood transfusion. Due to the risk of serious injury or death, the recall has been designated as Class I.

Clinical

Sanitation issue forces FDA recall of ventilator suction systems

Myval TAVR valve associated with positive durability data after 4 years

Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation

World’s first patient receives new-look heart pump—cardiologist ‘impressed’ by device’s performance

FDA issues Class I recall on infant heated wire circuits prone to disconnect