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 cardiologyheart failure, electrophysiologyhypertension, structural heart disease, use of pharmaceuticals, and COVID-19.   

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Boston Scientific enters renal denervation market with acquisition worth up to $540M

Boston Scientific has announced another significant M&A deal, scooping up an Israeli medtech company focused on RDN technology. 

FDA issues Class I recall on newborn resuscitation devices

The recall impacts products from ROi, supplied by Mercury Medical. A defective spring can cause a controller to malfunction, resulting in poor ventilation. 

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FDA announces recall of endoscope sheaths after 26 injuries

While there have been no reported deaths, certain lots of Olympus single-use guide sheath kits are to be quarantined immediately. 

The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA

FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.

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Request for an American Board of Cardiovascular Medicine denied—cardiology groups ‘deeply disappointed’

The ACC, AHA, HFSA, HRS and SCAI all worked together to try and make the new board a reality. Though their proposal has been denied, the groups say they are not done fighting. 

Why cardiac CT adoption remains low among primary care providers

The rapid rise of CCTA represents one of cardiology’s biggest ongoing trends, but most primary care providers are still not embracing a CT-first strategy.

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FDA sued over ‘reckless and arbitrary’ semaglutide decision

The Outsourcing Facilities Association, a Texas-based trade group, is alleging that supply issues still remain for Ozempic and Wegovy. The group believes the FDA has ignored those issues.

Teleflex to acquire Biotronik’s vascular intervention business for $791M, split into 2 separate entities

The acquisition helps Teleflex expand its interventional and vascular portfolios. Biotronik, meanwhile, is shifting its focus toward implantable devices and digital healthcare. 

Around the web

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. 

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

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?