In what represents the first PCT filing to be published in the name of Bayreuth, Germany-headquartered Incontalert GmbH, the company’s co-founders seek protection for a wearable device which employs machine learning techniques to non-invasively predict the bladder filling level for incontinence patients.

The European Council (EC) voted to approve the Artificial Intelligence Act (AI Act), a sweeping horizontal legislative product that affects all sectors of the European Union’s (EU) economy. Regulatory attorney Erik Vollebregt told BioWorld that the horizontal nature of the AI Act is still likely to exacerbate some of the problems already seen with the Medical Device Regulation (MDR) in a way that he said will make the EU market less attractive than is already the case.

News out of the Heart Rhythm Society 2024 meeting May 16-19 highlighted the rapid disruption pulsed field ablation (PFA) devices have wrought in cardiac arrhythmia treatment, so it is little surprise to see that PFAs are among the top five technologies with transformative potential identified by Clarivate plc in its Medical Technologies to Watch in 2024 report. The impact of the other four – continuous glucose monitors (CGM) for diabetes, neurostimulation devices, surgical robotics and renal denervation – has been just as revolutionary, if longer in being realized.

Pheon Therapeutics Ltd. is poised to start the first of three clinical trials of its lead antibody-drug conjugate (ADC), after closing a $120 million series B. The company is taking a “three-pronged approach” in order to stake out as much of the ground as it can for its next-generation ADC, which delivers an in-house-designed topoisomerase inhibitor to a novel undisclosed transmembrane protein target.

Elixir Medical Corp. reported positive 12-month clinical data from the Desyne BDS Plus randomized controlled trial which evaluated its Desyne BDS plus system, a triple drug-eluting coronary implant with site-specific antithrombotic therapeutic coating, against a contemporary, durable polymer drug-eluting stent in the treatment of de novo native coronary artery lesions.

Liquid biopsy typically means blood testing, but several companies presenting at Biomed Israel May 21-23 have developed diagnostics that look to other, even less invasive options, and ever broader applications. Nevia Bio Ltd. is using vaginal secretions to detect ovarian cancer, while Early OM Ltd. and Nucleix Ltd. analyze urine for cancer biomarkers.

One-year data from the Notion-2 trial, which compared transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) in younger low-risk patients with severe tricuspid or bicuspid aortic valve stenosis, showed little difference in clinical outcomes between the two procedures. The results were presented at the recent EuroPCR conference in Paris.

Elixir Medical Corp. revealed that data from the Pinnacle I study has validated the safety and effectiveness of its Lithix Hertz contact intravascular lithotripsy system to treat moderate to severe calcified coronary artery lesions by percutaneous transluminal coronary angioplasty.

There should be no more excuses to the adoption of renal denervation (RDN) as a treatment for hypertension given the recent approval by the U.S. FDA of two technologies and a range of guidelines recommending the therapy, delegates heard at the EuroPCR conference in Paris. In a discussion on the technology, panelists argued that on the back of solid evidence, RDN should be offered as a treatment given that the therapy is a safe method to reduce high blood pressure.

Newco Commit Biologics ApS has arrived on the scene after raising €16 million (US$17.2 million) in a seed round to advance bispecific antibodies that are designed to activate the complement system and direct it to selectively kill cancer cells.