The US Senate is considering a bill to expand Medicare coverage for breakthrough devices and diagnostics, removing the five-per-year limit imposed by CMS’ Transitional Coverage for Emerging Technology (TCET).
A bipartisan bill recently introduced in the US Senate attempts to upgrade Medicare’s coverage policy for devices and diagnostics that emerged from the Food and Drug Administration’s Breakthrough Device Pathway.
The legislation, known as the Ensuring Patient Access to Critical Breakthrough Products Act, was introduced by Sens
Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.
King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.
Apart from the reimbursement-driven turbulence in diagnostics, other aspects of Danaher’s China business are showing signs of resilience. Patient volumes remain strong and the company does not see evidence that the Chinese government is attempting to actively push Western suppliers out of its healthcare system.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
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.
Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?
