Data from the Drai Martini study shows that artificial intelligence is shaking up the analysis of electrocardiograms. Results presented at the recent ESC Congress 2024, demonstrated that an AI algorithm, Deeprhythmai, developed by Medicalgorithmics Sp zo.o., has significantly higher sensitivity than human specialists in detecting heart rhythm disorders on long ECG recordings.

The European Medicines Agency advised its member state regulatory partners to closely track how they use LLMs in making regulatory decisions – a clear signal that some regulatory decisions may be inappropriately torqued by their well-known shortcomings.

Brightflow SAS raised €16.5 million (US$18 million) in a series A financing round that will go towards developing its right ventricular mechanical circulatory support system. The company is working towards bringing the first long-term fully percutaneous implantable pump for right-sided heart failure to the market, Sophie Humbert, CEO at Brightflow, told BioWorld.

In the first study to compare transcatheter aortic valve replacement or implantation to surgical aortic valve replacement exclusively in women, Edwards Lifescience Corp.’s Sapien 3 and Sapien 3 Ultra valves provided better outcomes.

Angiodynamics Inc. received CE mark approval for its Auryon atherectomy system which treats peripheral artery disease, including critical limb ischemia and in-stent restenosis. The regulatory clearance expands the company’s global reach as it sees increasing revenues from sales of the device.

Elixir Medical Corp. reported positive 12-month data from the Infinity-Swedeheart trial that compared its Dynamx coronary bioadaptor system to Medtronic plc’s Resolute Onyx zotarolimus drug-eluting stent in patients requiring percutaneous coronary intervention with coronary artery disease.

In what represents Vienna, Austria-based Valeriot GmbH’s first patenting, its founder and CEO, Michael Flatscher, describes their invention of a device, Autovein, for use in no-touch vein harvesting which overcomes the issues faced with traditional vein harvesting techniques which are laborious, prone to complications and challenging to master.

Hope for definitive resolution of the controversy about the superiority of transcatheter edge-to-edge repair of mitral valves over medical therapy in individuals with symptomatic heart failure and functional mitral regurgitation were dashed at the European Society of Cardiology meeting this weekend.

The European Court of Justice declared that the European Commission was out of bounds in attempting to thwart Illumina Inc.’s proposed reacquisition of Grail Inc., which Illumina said relieves it of a fine of roughly €430 million (US$474.92 million).

The U.K. National Institute for Health and Care Excellence sees some evidence that single-step insertions of scaffolds for knees with damaged cartilage offer significant benefits, calling for the use of registries for tracking of outcomes data.