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FDA clears next-generation cardiac mapping software

San Diego-based Vektor Medical first secured FDA clearance for the AI-powered technology back in 2021. This updated announcement covers the latest version, which includes atrial flutter mapping and several other new features.

Noteworthy AI news: Prez Trump vs. state regulators, HHS’s AI strategy 1 week out, imperfect AI, more

State-level regulation of AI: President Trump has turned his thinking into action.

Arnold Seto, MD, MPA, FACC, FSCAI, cath lab director, Long Beach VA Medical Center, professor of medicine at Charles Drew University, Society for Cardiovascular Angiography and Interventions (SCAI) treasurer and chair of the SCAI Advocacy Committee, explains changes in payment policy are making ambulatory surgical centers (ASC) and office based labs (OBL) more attractive to both cardiologists and larger health systems.

More interventional procedures may be coming to an ambulatory surgical center near you

ASCs have their limitations, but they are also associated with several benefits for cardiologists and patients alike.

New recalls announced for troubled heart devices—FDA previously urged customers to seek alternatives

These most recent recalls focus on a series of maintenance issues. In 2024, the FDA advised customers to transition away from the two devices and find alternative treatment options.

AI-powered FFR-CT software linked to considerable cost savings, accurate predictions

According to Heartflow, its AI offering saves health systems nearly $1,400 per patient thanks to reductions in unnecessary cardiovascular testing.

Lawsuit claims clinic used AI to record patient conversations without consent

According to attorneys representing a potential class action of plaintiffs, Sharp HealthCare was not forthcoming about its use of a tool for automatic note-taking. The technology allegedly captures everything said in an exam room, including sensitive details on diagnoses, and sends it to an offsite server.

White House executive order aims to curb ‘excessive’ state regulation of AI

President Donald Trump wants to establish an AI Litigation Task Force to challenge any AI laws that may “harm innovation.”

Lumexa Imaging raises nearly $463M from successful IPO

“Going public is not a finish line. It’s the beginning of our next chapter,” CEO Caitlin Zulla, MPH, said in prepared remarks Dec. 11.

Hospira, an Illinois-based pharmaceutical and medical device company owned by Pfizer, has issued a voluntary recall of two different drugs due to ongoing safety issues. The recall includes specific lots of labetalol hydrochloride injections and buprenorphine hydrochloride injections. Labetalol hydrochloride injections are used to control blood pressure in patients with severe hypertension.

Pfizer recalls 2 drugs, including 1 for hypertension, over safety concerns

The recall was put in place due to a leak risk that could make the therapies less effective and potentially lead to an infection.

Dozens of injuries trigger FDA recall of over 50,000 implantable tissue marking devices

The Class I recall, which is the most serious recall the FDA issues, comes after numerous adverse events and complications linked to the radiographic markers were reported.

Hologic recalling breast care devices after 71 injuries, FDA says

UPDATED: The alert pertains to the BioZorb and BioZorb LP radiographic markers, implanted in soft tissue to indicate the site for radiation therapy or other medical procedures.

'Too many cooks in the kitchen': How AI is both helpful and a hindrance to radiologists

Recent research suggests that, in many cases, radiologist performance only improves minimally with AI assistance.

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