Device makers and physicians alike were less than enthused about several features of the draft Medicare inpatient rule for fiscal year 2025, but thanks in part to support from the device industry, the final rule provides a new code that encompasses both left atrial appendage closure and ablation, a change that may reduce spending without dinging sales of these devices.

The U.S. FDA has made clear its expectations of batteries and accessories for automated external defibrillators, but at least one maker of replacement AED batteries seems to have not got the message.

An artificial intelligence algorithm developed at Sheba Medical Center in Israel can identify patients at high risk of pulmonary embolism as soon as they walk through the hospital doors, a study published in the Journal of Medical Internet Research found. Using only information available from the patient’s medical history, the machine learning tool flagged high-risk patients before the initial clinical checkup occurred.

In what represents the first patenting to emerge from Endeavor Med Inc., its founder and chief executive officer, Imran Faruqi, describes their development of a novel device capable of providing non-invasive cardiac pacing, defibrillation, and cardioversion, and which uses pacing currents at less than half that required by traditional chest pads.

Croívalve Ltd. raised $16 million in a series B financing round that will be used to fund a clinical trial in the U.S. looking at the safety and performance of its Duo system to treat patients with severe or greater symptomatic tricuspid regurgitation.

The recent €15 million (US$16.3 million) deal that Affluent Medical SAS signed with Edwards Lifesciences Inc. for its heart products does not take away from its ambitions of creating a European med-tech company, Sébastien Ladet, CEO of Affluent Medical, told BioWorld, but was part of the company’s broader strategy to expand the markets for its products.

The U.K. National Institute for Health and Care Excellence endorsed the use of testing for the CYP2C19 genotype for management of clopidogrel usage after ischemic stroke and heart attack, but the agency is specific about the use of tests by Genedrive plc and Genomadix Inc. in point-of-care settings as alternatives to lab testing.

Esperto Medical Inc. could soon offer a non-invasive method for blood pressure measurement for critically ill patients based on results seen in a study published in PNAS Nexus. Esperto’s Resonance Sonomanometry technology uses acoustic stimulation with ultrasound imaging to provide continuous, non-invasive readings.

Protembis GmbH received €20 million (US$21.66 million) in financing from the European Investment Bank to develop its cerebral embolic protection system, Protembo. The intra-aortic filter device deflects embolic material away from arteries leading to the brain during left-sided heart procedures including transcatheter aortic valve replacement.

The U.S. CMS proposed a series of changes to the Medicare series of codes for diagnostic-related groups, and device makers had pointed remarks about some of those proposals.