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When public health emergencies emerge, such as new infectious outbreaks, rapid access to reliable diagnostic tests is crucial. The FDA’s newly finalized guidance on IVDs during emergencies (September 2025) establishes a clear, structured framework for how the agency will manage diagnostic testing under Section 564 Emergency Use Authorization (EUA) declarations.

Dr. Shalini Gupta, Founder and CEO of Asima Health, left academia in Canada to develop decentralized, point-of-care cancer diagnostics that make early detection more accessible. Partnering with Arete Biosciences, a U.S. life sciences accelerator, Asima is advancing from prototype to clinical validation with sites in Chicago and Tampa. The company plans to launch its first CLIA-lab-based multi-cancer test next year, driving innovation in Canada-U.S. MedTech collaboration.

In the ever-evolving landscape of business and organizational management, consulting has emerged as a crucial tool for helping companies adapt and thrive.

Learn how to tackle financial hurdles with expert guidance.