FDA's New 510(k) Guidance: 5 Critical Changes for 2025
The FDA's updated 510(k) guidance introduces significant changes to predicate device selection and clinical data requirements. Here's what founders and investors need to understand.
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Regulatory updates, market analysis, and due diligence insights from the front lines of medical device investing.
After a sluggish 2024, medical device M&A is showing signs of recovery. We analyze the key trends, valuation multiples, and strategic priorities that will shape deal flow in the coming year—and what it means for your portfolio companies.
Read ArticleThe FDA's updated 510(k) guidance introduces significant changes to predicate device selection and clinical data requirements. Here's what founders and investors need to understand.
Read MoreWe've seen it too many times: a promising device company builds their entire regulatory strategy on a predicate that was never appropriate.
Read MoreEvery pitch deck now features "AI-powered" somewhere. But which AI medical device plays are actually defensible? We break down the regulatory realities.
Read MoreAn anonymized deep-dive into how a well-funded surgical device company missed every adoption signal. The warning signs were there at Series A.
Read MoreThe EU MDR timeline continues to shift. We analyze the latest guidance and what it means for US device companies planning European market entry.
Read MoreClinical efficacy means nothing if payers won't cover it. We outline the reimbursement diligence framework that separates fundable opportunities.
Read MoreOur team provides bespoke research and due diligence reports for specific deals and market opportunities.
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