CMS Proposes New TCET Pathway, But How Much Difference Will It Make?

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.