The European Union’s struggles with regulations for devices and in vitro diagnostics seem virtually endless, but the European Commission floated a series of changes that would present a significant reset of both regulations. One of the more sweeping changes would be to exempt medical technologies from much of the text of the Artificial Intelligence Act, a move that would ease the drag on AI-based technologies in the EU.

Siemens Healthineers AG became the latest company to sign a licensing agreement with Alzpath Inc. to use its pTau217 antibody in the development of a blood-based diagnostic assay for Alzheimer's disease. Alzpath previously signed deals with the likes of Roche AG and Beckman Coulter Diagnostics Inc. to use its pTau217 antibody to create diagnostic tests based for early detection and monitoring of Alzheimer's.

Ebenbuild GmbH is hoping that its digital twin technology platform that combines AI and physics-based computational models tailored to individual patients will transform respiratory care. From drug development to optimizing mechanical ventilation in critical care, the company’s software-based solutions aim to reveal what is happening in the ‘black box’ of the lungs, helping clinicians to improve outcomes and reduce mortality.

Alcon AG reported on Dec. 9 that it had sweetened its offer for intraocular lens maker Staar Surgical Co., raising its offer by roughly 10% to $30.75 a share from its prior bid of $28 a share. The revised offer comes on the heels of the expiration of Staar’s go-shop period on Dec. 8, in which Lake Forest, Calif.-based Staar said no superior offers were received.

Roche AG received CE mark for its cobas Bacterial Vaginosis/Candida Vaginitis assay, which will help to improve accuracy in detecting vaginitis in women. The molecular test identifies specific bacteria and yeast responsible for BV and CV from vaginal samples collected using the cobas PCR Media proprietary tube.

The UK Health Security Agency (UKHSA) has identified a new recombinant strain of mpox (formerly monkeypox) that contains elements of clade Ib and clade IIb of the virus, in a traveler who recently returned from Asia. In a paper describing the new strain, the researchers at UKHSA say it is not possible to determine from a single genome how long the recombinant virus has been in circulation, or whether it will have a fitness benefit over currently circulating lineages.

Teleflex Inc. reported plans to sell its Acute Care, Interventional Urology and OEM businesses to two buyers for $2.03 billion. Intersurgical Ltd. will acquire the Acute Care and Interventional Urology units for $530 million. Additionally, private equity firms Montagu and Kohlberg are buying its OEM contract manufacturing business for $1.5 billion.

Levron Medical Ltd. recently exited stealth mode to advance its cardio-respiratory physiology assist technology, designed to treat heart failure by synchronizing the heart and lungs. The approach harnesses the natural ‘respiratory pump’ to assist cardiac function and create what the company claims to be a new category of heart failure treatment.

The first procedure to treat benign prostatic hyperplasia with Boston Scientific Corp.’s next-generation Rezūm EVO Console was successfully completed in the U.K. The device, which recently received CE mark, is intended to be used with the Rezūm Water Vapor Therapy, a minimally invasive treatment that uses water vapor to reduce prostate tissue.

Roche AG received regulatory clearance from the U.S. and European authorities for a new diagnostic test that detects Bordetella infections, including whooping cough, as cases surge globally. The point-of-care test, which delivers PCR-accurate results in just 15 minutes, will help health care providers to quickly identify infections and act to prevent severe complications, onward transmission and deaths.