JD Supra

FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part II: FDA’s Proposed Phaseout Policy - Key Considerations & Open Questions

After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If finalized as proposed, FDA would ...
JD Supra

CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

A laboratory director of a nonwaived lab who holds a doctor of medicine (MD) or doctor of osteopathy (DO) degree must also be certified in anatomic pathology or clinical pathology, or both, by the ...
MedTech Dive

Labcorp expands Epic pact to make full test menu available on Aura

The Labcorp agreement continues the expansion of Aura, which gives healthcare providers access to tests from companies ...
Business Wire

Luminate Health Leads Direct-to-Consumer Lab Testing Market, Expanding Laboratory Reach, Accessibility, and Growth

SAN MATEO, Calif.--(BUSINESS WIRE)--Luminate Health, a leader in healthcare technology solutions for the clinical laboratory and diagnostics market, has seen unparalleled success with the adoption of ...