Regulatory & Reimbursement
FDA Output, October 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in October 2026. Updated October 22.
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Regulatory & Reimbursement
The Controversy Over Multi-Cancer Early Detection Tests: What’s Next?
In September, a high-profile FDA advisory committee panel recommended regulatory approval of GRAIL’s multi-cancer early detection screening test, paving the way for a new paradigm in diagnostics. Wall Street and companies working on MCEDs responded favorably, and GRAIL’s stock jumped. The panel opinion has nuances, however, and the next steps will be critical in sorting out an opportunity that is guaranteed to be complicated, as well as exciting.
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ICYMI
A Push to Invest in Innovation-Focused M&A
Medtech companies, weighed down by depressed stock prices and market challenges, are under intense pressure to step out of their comfort zones and make bets on innovation that will drive their future. Excerpted from our recent feature article, Despite Headwinds, A Nascent Medtech Rebound Is Fueling M&A.