Diverse voices across medtech are urging US lawmakers to include the VALID Act as part of the year-end omnibus package. Advocates say the legislation would create a uniform standard for diagnostics.
The Pew Charitable Trusts and eight other groups representing patients, clinicians, and medical device manufacturers are pushing Congress to include legislation in the year-end omnibus spending package that would finally update regulation of laboratory-developed tests (LDTs).
Currently regulated under the 1988 Clinical Laboratory Improvement Amendments (CLIA), LTDs are not centrally registered or tracked, which proponents of reform say makes it difficult to assess their efficacy
A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.
Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.
US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.
