Califf Says US FDA’s Role In Artificial Intelligence/Machine Learning Development Is ‘Convener'

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.

Cambridge-based startup Mursla Bio's liquid biopsy test EvoLiver uses extracellular vesicles to detect hepatocellular carcinoma (HCC) in high-risk cirrhotic patients. Medtech Insight sat down with with Mursla Bio CEO Pierre Arsène.

Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.