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.   

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FDA announces recall after Philips heart monitor software failed to send alerts—multiple deaths reported

Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries. 

HRS President Ken Ellenbogen, MD, FHRS, explains the need for the Heart Rhythm Advocates lobby group in Washington, D.C. to push for policies in Congress over reimbursements.

Why electrophysiologists needed a champion in Washington

Heart Rhythm Society President Kenneth A. Ellenbogen, MD, detailed a new advocacy group focused on improving EP reimbursements, patient care and access. “If you’re not at the table, you’re on the menu," he said.

FDA has now cleared more than 1,000 AI models, including many in cardiology

Cardiology is the medical speciality with the second most FDA clearances overall. 

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Boston Scientific enters IVL arms race with acquisition worth up to $664M

Boston Scientific has agreed to acquire Bolt Medical, a California-based medical device company focused on developing new intravascular lithotripsy technologies. The news comes less than one year after Johnson & Johnson acquired IVL pioneers Shockwave Medical for $13 billion.

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Stryker acquires Inari Medical for $4.9B

Stryker, a global medtech company based out of Michigan, has kicked off 2025 with a bit of excitement. The company says Inari’s peripheral vascular portfolio is highly complementary to its own neurovascular portfolio.

Withings, a French medtech company known for its remote monitoring devices, has multiple new services on display at CES 2025.

CES 2025: Cardiologist check-ups, AI-powered smart mirrors coming to heart patients’ homes

Healthcare companies from all over the world are showing off their newest cardiovascular offerings at CES 2025 in Las Vegas.

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FDA issues proposed guidance for improving reliability of pulse oximeters

The devices struggle to accurately read blood-oxygen levels in patients with darker and thicker skin. The FDA hopes that changes in design and improved clinical trials will improve clinical efficacy.

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FDA issues warning on endoscopes after injuries, death from infections

All lots of Olympus-branded endoscopes are subject to an alert from the FDA, due to a sanitation issue associated with improper reprocessing. 

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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?