Israeli firm DreaMed has scored a new US Food and Drug Administration clearance for its AI-based diabetes decision support system Advisor Pro. The clearance enables physicians to use the software for patients with type 1 diabetes using continuous glucose monitoring (CGMs) and blood glucose meters (BGMs).

It was another record year for novel device approvals by US FDA, driven by the big uptick in de novo classifications for low-to-moderate-risk devices in 2018. Meanwhile, original PMA approvals dropped significantly. An analysis and infographic on FDA device approval trends in 2018.

Medtronic's outcomes-based insulin pump supply deal with Aetna is the latest example of the medtech industry's shift toward value-based care.

Mega-deals and innovative technologies have transformed advanced wound care into a robust, high-tech market in the US. While regulatory and reimbursement challenges persist, opportunities in adjacent spaces and under-penetrated OUS markets represent fertile ground for advanced wound care expansion.