Plexāā Ltd. recently raised $4.5 million to support the upcoming U.S. launch of Bloom43, its wearable device that helps patients prepare for breast cancer surgery and reconstruction by using a technique called supraphysiological preconditioning.

The U.K. Medicines and Healthcare Products Regulatory Agency unveiled another round of measures designed to promote access to the latest medical technology, which includes a move to jettison domestic device markings in favor of unique device identifiers.

Directsens GmbH recently signed a collaboration agreement with Metage, an Austrian research consortium, to advance a test for the early detection of type 2 diabetes. The focus of the partnership will be on validating Directsens’ Xpressgt assay, which measures 2-hydroxybutyrate levels in venous blood, and could be used by clinicians to inform patients they are at risk of developing type 2 diabetes.

Uromems SAS received investigational device exemption (IDE) approval from the U.S. FDA, and clearance from the French National Agency for the Safety of Medicines and Health Products (ANSM), to begin a pivotal trial of its Uroactive smart implant.

The U.K. government has committed to reduce the cost of drug and device approvals by 25% as part of a long-awaited life sciences strategy which sets out a 10-year plan for the sector.

After a 10-year project and a £60 million (US$80 million) investment, the UK Biobank has completed the whole body scans of 100,000 volunteers and is making the 1 billion images available for researchers worldwide.

Caranx Medical SAS secured clearance from the U.S. FDA for Tavipilot Soft, its AI-powered software which provides real-time intraoperative guidance during transcatheter heart valve replacement (TAVR) procedures. The software, which tracks anatomical and instrumental landmarks in real-time to enable precise and accurate heart valve positioning and delivery, will allow a broader number of cardiologists to perform this complex procedure.

The U.K. National Institute for Health and Care Excellence (NICE) has endorsed the use of pulsed field ablation for atrial fibrillation, and while several trusts in the U.K. are already using these devices for their patients, the endorsement is certain to expand utilization in the U.K., which according to data from Clarivate’s Epidemiology Intelligence may come to nearly 4 million.

Comphya SA raised CHF 7.5 million (US$ 8.4 million) in a series A round for its implantable neurostimulation therapy, Caverstim, which treats men with erectile dysfunction who do not respond to medication.

Plasmacure B.V. secured €6 million (US$7 million) in series A funding for its Plasoma cold plasma system to treat complex wounds. The round was led by Venture Medical LLC, a U.S.-based provider of solutions for wound care, which also committed to spend over $10 million to support regulatory approval, reimbursement and U.S. market expansion of the Plasoma technology.