AdvaMed’s new online clock documents the time since CMS promised to replace MCIT, a program guaranteeing coverage for FDA-cleared breakthrough devices.

The National Academy of Medicine developed a code of conduct for health care AI development, as well as commitments for code implementation. 

Abbott’s trial win for patent infringement by DexCom’s CGM systems still doesn’t have information on damages awarded due a hung jury.

J&J’s acquisition of IVL device maker Shockwave Medical for $13.1bn sets J&J’s medtech arm solidly in a leadership position in multiple cardiovascular markets.

This week, Abbott, Click and Otsuka, Prenosis won the FDA nod respectively for an in vitro diagnostic to evaluate patients for concussion, the first prescription digital therapeutic to treat major depressive disorder and a software to predict sepsis. Also on the regulatory front, the FDA will now take 513(g)s forms via its eSTAR framework. In Europe, the debate of what personal information can be shared continues.