New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Position paper offers seven key recommendations for addressing inequities and disparities in access to quality health care in the US.
The precision medicine company recently announced a pair of strategic alliances aimed at expanding access to new cancer diagnostics.
Court rejects laundry list of defenses of a Texas hospital’s president who was convicted for his role in a $158 million PHP fraud scheme.
The FDA recently granted 510(k) clearance to StrivePD, a platform for collecting Parkinson’s patients’ symptom data via the Apple Watch.
The owner, who also owned several telemarketing companies and committed tax evasion of just over $4 million, now faces 14 years in prison.
The companies are working together to explore LabDroid’s capacity to automate sample preparation workflows for long-read sequencing systems.
Move to exclude testimony regarding potential patient impact of lab deficiencies as hearsay is dismissed by the court.
In clinical training sets, the new test allowed SARS-CoV-2 antibodies to be detected using widely available glucometers.
The UK-based diagnostics firm received CE marks for a diabetes test, CHF test, as well as an analyzer, and two COVID-19 tests.
Combined with rising labor costs, COVID-19, and other challenges, stakeholders say the cuts will negatively impact patient care.