FDA Output
FDA Output, August 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in August 2026. Updated August 20.
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Investors & Dealmaking
Record Series A's, Robust Late-Stage Deals in H1 2026, But Are There Exits?
The first half of 2026 saw record first financing activity in medtech, including nine $20 million-plus deals, and robust late-stage deals of $50 million or more, according to a mid-year 2026 HSBC Venture Healthcare Report, but concerns about exits and lagging interest in some indications linger. Jon Norris, managing director at HSBC, and lead author, discusses recent medtech trends with MTS' Wendy Diller in a two-part video interview.
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Regulatory & Reimbursement
Pathways' Pick of the Week: Modernizing Inspections
FDA lays out a new vision for inspections. Excerpted from Pathways Picks August 5: Medicare Tightens NTAP Access, MDUFA Money, UK on AI Scribes, and More.