The Skincubator is a wearable designed to enable immediate, prolonged skin-to-skin care for the tiniest preterm infants in ...

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 ...

Ceribell’s LVO Stroke tool is underpinned by the same EEG monitoring technology used in its seizure and delirium monitoring ...

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 ...

When it comes to approving medical devices, the U.S. Food and Drug Administration can be notoriously slow. To speed up the process, about ten years ago, the FDA launched its Breakthrough Device ...

AdvaMed and 66 other groups have asked the Centers for Medicare and Medicaid Services to create a streamlined pathway for covering breakthrough medical devices. A letter to CMS Administrator Dr.

Since the Food and Drug Administration launched its breakthrough device program in 2016, it’s tapped more than 1,000 products with the label. The goal: to get innovative devices reviewed faster, and ...

Physicians are in short supply. They are costly. Is the APP the answer to the CMO's workforce and budget challenges? ... In a social media landscape shaped by hashtags, algorithms, and viral posts, ...

Orchestra BioMed Holdings' AVIM product received FDA breakthrough device designation, accelerating approval and offering speculative optimism for investors. The firm is pre-revenue with significant ...