AACC
The rule could force labs to shed tests deemed nonessential to their institutions' missions as well as influence decisions around instrumentation and vendor choices.
At the ADLM annual meeting, firms said they see game-changing opportunities for platforms that provide the right combination of clinical utility and convenience.
The organization's priorities also include developing appropriate pediatric reference intervals for diagnostic tests.
Two years after the IVDR started taking effect, changes to the regulations, including new deadlines, have meant continued uncertainty for firms and labs.
As AI-Based Diagnostics Proliferate, Stakeholders Strive for Regulation Without Stifling Innovation
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Regulators in the US and Europe have said that they are considering how they could regulate artificial intelligence-based models with frequent algorithm updates.