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.

FDA announces new recall of Medtronic surgical devices over safety concerns
The agency warned that any unused devices should be removed from the market and returned to the manufacturer.
FDA sees promise in new AI model for heart attack detection
Powerful Medical's advanced algorithm was designed to detect STEMI and STEMI-equivalent patterns in a patient’s ECG results.
Heart transplants at VA medical center shut down after patient deaths
Safety incidents extend the halt at Richmond VA Medical Center into its 19th month, as the United Network for Organ Sharing launches its own investigation following an internal probe by Veterans Affairs.
CMS approves Medicare coverage for transcatheter tricuspid valve replacement
CMS will cover TTVR for the treatment of symptomatic tricuspid regurgitation on a national level. The agency first proposed such a policy in December, taking time to consider public comments before finalizing its decision.
Safety update: FDA announces Class I recall due to atherectomy devices breaking during use
The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.

FDA clears Google smartwatch tech that calls 911 when a user’s heart stops

Google worked with AI specialists, cardiologists and even stunt performers to develop its new smartwatch feature.

Walgreens resolves $595M lawsuit over COVID testing

The dispute was with Everly Health, a telemedicine provider contracted to fulfill orders for COVID-19 tests during the pandemic. Walgreens was accused of violating provisions of a service agreement.

FDA announces Class I recall of Boston Scientific pacemakers—replacement may be necessary

These safety issues have been linked to more than 800 injuries and two deaths. It is possible, the FDA warned, that some patients may require a device to be removed and replaced.

FDA ends semaglutide shortage, closing the door on compounded Wegovy, Ozempic

The years-long shortage of Wegovy and Ozempic, two popular prescription-only semaglutide injections, is officially over.

heart data research doctor cardiologist AI

American Heart Association highlights importance of NIH as battle over Trump funding cuts continues

“Now more than ever, we must recognize that our country’s leadership in groundbreaking medical research spurs scientific innovation, improves public health and creates new innovations that save and improve lives nationwide,” Joseph C. Wu, MD, PhD, explained in a statement.

Cardiologist questions FDA’s approval process for high-risk medical devices

The technology used to diagnose, treat and manage cardiovascular disease is always evolving, keeping FDA officials quite busy. But have the agency's standards been slipping in recent years? A cardiologist with Cedars-Sinai Medical Center explored that very question.

Getinge ending production of cardiopulmonary surgical perfusion systems

The global medtech company is also looking to expand its organ transplant and ECMO portfolios.

Data trove of 1.6M patient records discovered online

A cybersecurity researcher made the discovery. The database, in the care of a clinical trials company, was not password protected or encrypted.

Around the web

Cardiovascular Business

ACC urges RFK Jr. to make Medicare reform a priority, warns against mass layoffs

The American College of Cardiology has sent a letter to HHS Secretary Robert F. Kennedy Jr. that outlines some of the organization’s central priorities and concerns.

Radiology Business

FDA announces recall of Medtronic interventional radiology devices after 17 injuries, 4 deaths

One product is being pulled from the market, and the other is receiving updated instructions for use.

AI in Healthcare

What federal regulators can learn from the states about AI oversight

If the Trump administration continues taking a laissez-faire stance toward AI—including AI used in healthcare—why not let the states go it alone on regulating the technology?

Clinical

FDA announces new recall of Medtronic surgical devices over safety concerns

FDA sees promise in new AI model for heart attack detection

Heart transplants at VA medical center shut down after patient deaths

CMS approves Medicare coverage for transcatheter tricuspid valve replacement

Safety update: FDA announces Class I recall due to atherectomy devices breaking during use

Around the web