Bringing Clinical Mass Spectrometry into Routine Medical Laboratory Testing
Roche experts discuss the company’s recently launched automated solution and how it will bring mass spec to more patients
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Roche experts discuss the company’s recently launched automated solution and how it will bring mass spec to more patients
The decision deepens a split among circuit courts regarding how to determine liability for false claims
ACLA president Susan Van Meter discusses some of the key issues labs faced in 2024, along with work to address these developments through 2025
Experts say new leadership could impact the cost and availability of IVDs as well as patients’ ability to afford lab testing
In vitro diagnostic products approved by the U.S. Food and Drug Administration in 2024 show a continued move toward rapid and point-of-care tests
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
The most common AI compliance risk areas related to data security and patient privacy, and the current regulatory landscape
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
Though needed to protect data and patient privacy, some in the industry say that more flexibility is needed
The current landscape of medical laboratory networks and challenges that will need to be addressed to improve data sharing and efficiency.