Hannah Daniel
Senior Reporter
Latest From Hannah Daniel
It’s Been Over 1100 Days Since MCIT, Still No TCET In Sight
AdvaMed’s new online clock documents the time since CMS promised to replace MCIT, a program guaranteeing coverage for FDA-cleared breakthrough devices.
NAM’S Health Care AI Development Code Of Conduct Addresses Gaps In Current Principles
The National Academy of Medicine developed a code of conduct for health care AI development, as well as commitments for code implementation.
Abbott Eagerly Awaits Damages Won From DexCom Patent Suit
Abbott’s trial win for patent infringement by DexCom’s CGM systems still doesn’t have information on damages awarded due a hung jury.
Johnson & Johnson Poised To Lead Multiple Cardiovascular Markets With Shockwave Medical Acquisition
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.
News We're Watching: Abbott, Click, Otsuka, Prenosis Win FDA Approval; EU Health Data Space Proposal, And More
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.
Medtech Connect 14: Live From HIMSS
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.