This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.  

Xeltis’ aXess graft demonstrated high patency rates and no infections after six months in the first-in-human trial.

Xeltis hemodialysis access graft, made of its proprietary electrospun supramolecular polymer material, is advancing in clinical trials in Europe and will likely be ready for a US trial by the end of this year, according to the company.

LSP says its new fund for medical device and drug development companies will be the biggest fund dedicated to life sciences companies in Europe.