Heartbeam Inc.'s algorithms performed as well on a standard 12-lead electrocardiography (ECG) as on its 3D ECG system in the detection of atrial fibrillation, atrial flutter and sinus rhythm, based on a study presented by Joshua Lampert, cardiac electrophysiologist and medical director of machine learning at HRX Live 2025 in Atlanta.

The U.S. Office of Inspector General posted an analysis of Medicare spending on skin substitutes, remarking that the data suggest a disproportionate use of these products for patients enrolled in fee-for-service (FFS) care.

Edwards Lifesciences Corp. fully acquired Vectorious Medical Technologies Ltd. for $497 million, following a series of investments in the heart failure technology company over the last five years.

Sometimes little things can create big problems, which seems to be the case with the recall of the power unit used with the Abbott Heartmate 3 left ventricular assist device (LVAD). According to the FDA recall announcement, the power cords used with the power supply might not stay fixed in place, which would leave the power supply with 15 minutes of backup battery runtime before depletion.

The U.S. FDA cleared Respiree Pte. Ltd.’s 510(k) for its RS-001 cardio-respiratory wearable that measures respiration and offers passive cardio-respiratory monitoring.

You can’t fault Alcon AG’s focus. In the midst of an extended series of acquisitions, the company has a clear vision of creating a deep ophthalmic treatment pipeline – and diagnostics fall outside that line of sight.

The U.S. Department of Health and Human Services (HHS) reported Sept. 3 that it will engage in “active enforcement” of information blocking rules, each violation of which carries a fine that may reach seven figures.

Sparks flew both ways Sept. 4 as Democratic senators pushed for Robert Kennedy to resign as secretary of the U.S. Department of Health and Human Services (HHS) during a Senate Finance Committee hearing ostensibly held to discuss the Trump administration’s 2026 health care agenda. But with Kennedy the only witness, the hearing focused on Kennedy’s perceived failings as HHS secretary. “The United States is in the midst of a health care calamity,” Ranking Member Ron Wyden, D-Ore., said in his opening comments, which were laden with personal attacks.

Kardium Inc.’s Globe pulsed field system received U.S. FDA premarket approval, making it the fourth PFA system in the rapidly expanding market for cardiac ablation for atrial fibrillation. The system’s introducer sheath and mapping software also received clearance.

The Sept. 3 congressional hearing on AI in health care raised questions about whether the U.S. FDA enjoys the statutory authorities it needs to properly regulate this class of products, but witnesses at the hearing said a lack of trust in AI is a substantial roadblock to adoption.