Software Pre-Certification Program Highlights Needs For Legislative Change, FDA Says

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

Proposed tariffs on semiconductors from President Donald Trump could significantly raise costs for the US medical device industry. Current domestic production cannot meet demand, spurring concerns about potential price increases for consumers and healthcare systems.

Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.