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- VertigoDx receives FDA 510(k) clearance for its portable SmartVertigo diagnostic systemThe U.S. Food and Drug Administration has issued a 510(k) clearance for VertigoDx's portable vertigo assessment tool, allowing it to be marketed in the United States. The system, called SmartVerti…
- Industry groups back FDA draft guidance on single‑trial approvals but seek clearer flexibility rulesIndustry associations and other stakeholders have expressed overall support for the FDA's draft guidance that outlines when a single pivotal trial, supplemented by confirmatory evidence, can be suf…