LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Novel Pathogen Reduction Technologies Effectively Treat Whole Blood Products
Researchers are actively developing PRTs for use in whole blood products to target bacteria and viruses, including SARS-CoV-2.
ACP: Current Physician Payment Model Needs to Be Reformed
Position paper offers seven key recommendations for addressing inequities and disparities in access to quality health care in the US.
Tempus Partners to Advance Genomic Cancer Testing
The precision medicine company recently announced a pair of strategic alliances aimed at expanding access to new cancer diagnostics.
Federal Court Upholds $46.7 Million Medicare PHPs Fraud Conviction
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.
Recent FDA Clearance Allows Patients to Track PD Symptoms via Apple Watch
The FDA recently granted 510(k) clearance to StrivePD, a platform for collecting Parkinson’s patients’ symptom data via the Apple Watch.
Telemedicine Companies Owner Sentenced in $20M Healthcare Fraud Scheme
The owner, who also owned several telemarketing companies and committed tax evasion of just over $4 million, now faces 14 years in prison.
PacBio and RBI Collaborate on Lab Sequencing Robot
The companies are working together to explore LabDroid’s capacity to automate sample preparation workflows for long-read sequencing systems.
Theranos In Court: Balwani Lawyers Dealt Another Blow
Move to exclude testimony regarding potential patient impact of lab deficiencies as hearsay is dismissed by the court.
New Method Could Lead to an At-Home Test for COVID-19 Antibodies
In clinical training sets, the new test allowed SARS-CoV-2 antibodies to be detected using widely available glucometers.
LumiraDx Gets CE Clearance for Five Different Products
The UK-based diagnostics firm received CE marks for a diabetes test, CHF test, as well as an analyzer, and two COVID-19 tests.
