The US Food and Drug Administration’s (FDA’s) Breakthrough Devices Program was established to facilitate earlier patient access to novel medical devices addressing serious health conditions, by ...

Questions about cost and patient benefit loom as Congress considers automatic Medicare coverage for 'breakthrough' medical ...

The EU’s Medical Device Coordination Group (MDCG) posted two guidances in the waning weeks of 2025, one of which deals with postmarket surveillance for both devices and diagnostics. Another guidance ...

CMS said Nov. 12 it will rescind a rule introduced by former President Donald Trump’s administration that allows Medicare to quickly cover medical devices deemed “breakthrough” technologies by the FDA ...

FDA has granted breakthrough device designation (BDD) for the Skincubator, a wearable device designed to enable immediate, prolonged skin-to-skin care for the tiniest preterm infants in their first ...