Regulatory & Reimbursement
FDA Output, February 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in February 2026. Updated February 26.
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Investors & Dealmaking
2025 Data Is In: Diagnostics Is Having a Renaissance
The diagnostic industry, a perpetual valuation laggard to higher-profile subsectors of the life sciences, with a short-lived exception during the height of COVID-19, may finally be having a moment. Reflecting this optimism, industry experts on a recent Arizona State University online seminar highlighted the success of rising young and increasingly profitable tech-enabled diagnostics companies, labeling them the “Terrific 10,” a moniker that references the tech industry’s “Magnificent 7.”
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ICYMI
PFA Jolts the EP Market
Pulsed field ablation is set to supplant radiofrequency and cryoablation as the preferred catheter-based approach to stopping arrhythmias. Because it is safer and faster than older technologies, it is helping electrophysiologists treat more patients and accelerate the overall growth of the cardiac ablation business. Excerpted from our recent feature, "PFA Is Ready to Electrify the Electrophysiology Market."