The U.K. Medicines and Health Care Products Regulatory Agency is considering a policy of mutual recognition of medical devices that have won marketing authorization in four other jurisdictions, including the U.S. and the EU. While there are significant exclusions – such as for some articles that qualify as software as a medical device – this policy would be in force at some point in 2025, easing the path forward for products in a market that is home to nearly 67 million potential patients.

Boston Scientific Corp. is hoping to help change European guidelines on the use of intravascular imaging during percutaneous coronary intervention procedures, Emile Mehanna, medical affairs and medical education director, interventional cardiology, EMEA, told BioWorld.

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.

Milleporesigma, Merck KGaA’s North American life sciences business, agreed to acquire Mirus Bio LLC from Gamma Biosciences LP for $600 million. Mirus develops tailored transfection solutions that deliver nucleic acid into cells used in production of viral vector-based gene therapies. It also provides contract development and manufacturing services. The transaction is expected to close in the third quarter of 2024, subject to U.S. regulatory approvals and customary closing conditions.

Abbott Laboratories announced a class I recall of the Heartmate 3 left ventricular assist system (LVAS) that affects nearly 890 units distributed over the past three years, a move triggered by reports of blood leakage or air entry into the device during implant procedures.