With a laser focus on structural heart care, the company's transcatheter aortic valve replacement technology proved superior and gained approval among patients once considered better candidates for open heart surgery, lifting its stock more than 60%. Read more ➔

Stryker's year was shaped by two of the biggest fruits of the newly minted AdvaMed chairman's dealmaking: expansion of the Mako robot and the addition of Wright Medical. Read more ➔

The new European Union Medical Device Regulation requires more devices to undergo notified body review than ever before. But there are worries there aren't enough notified bodies to handle the workload. Read more ➔

As tech-led diabetes management becomes more mainstream, the "lead horses" in continuous glucose monitor manufacturing have committed to multiplying production capacity and are eyeing expansion into new populations. Read more ➔

New efforts by FDA to build out the program come years after the Institute of Medicine recommended scrapping it. More than 80% of devices are cleared through the pathway, so small changes can be meaningful to product safety. Read more ➔