Heart device impresses FDA | Stryker acquires Inari Medical for $4.9B | CES 2025 | Limiting TAVR complications

The new atrial shunt from Alleviant Medical was designed to treat heart failure without leaving a permanent implant behind. The FDA granted the technology its breakthrough device designation and approved additional research. 

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.

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

Radial access is already the primary choice for many cardiologists performing PCI due to a lower risk of complications. The same appears to be true for secondary access during TAVR.

Michael Reardon, MD, co-principal investigator of the ACURATE IDE trial, discussed updated data on what may have impacted that study's findings.

The FDA-approved Harmony TPVR system is now available to patients across the EU. Nina Goodheart, president of Medtronic’s structural heart and aortic business, described the news as a "significant milestone."

The popular GLP-1 receptor agonist appears to help limit adverse events and new-onset diabetes in patients with a history of CABG. Researchers shared the full study in the Journal of the American College of Cardiology.

The U.S. Food and Drug Administration issued the recall notice for more than 200,000 pacemakers because a battery issue could lock the device in safe mode. 

Remote patient monitoring helps clinicians track heart patients as they recover from major operations. One surgeon described the technology as a "game-changer," highlighting the confidence patients feel when they have "an extra set of eyes on them."  

SCAI President James Hermiller, MD, recently outlined the key achievements for 2024, including creation of the first interventional cardiology match program, successful advocacy and efforts to increase women in the field.

Gynesonics developed and sells the Sonata System, the first FDA-cleared product for diagnosis and treatment of certain symptomatic fibroids. 

Some FDA-approved medical devices age more safely than others. That’s no less true of AI-enabled technologies than of any others. The agency spells out the ramifications in draft guidance issued this week.