US Approvals Analysis: Stroke Device, IVDs Highlight October FDA Actions
• By David Filmore
A PFO-closure device was finally approved for stroke in October. Also during the month, important personalized medicine diagnostics approvals and a next-gen robotic system for stent procedures.
The ceramic device, designed to reduce complications, will be exclusively distributed by Zimmer Biomet and initially available in 30 hospitals, with broader European access expected by 2026.
Philips says the expansion of its facility in Reedsville, PA, will not only boost its capacity to produce AI-enabled ultrasounds that are used in hospitals across the US but will also create 120 well-paying jobs.
AI-driven medtech M&A slowed slightly in volume but tripled in value in early 2025, with buyers focusing on AI-driven diagnostics, surgical tech and analytics. Industry experts expect continued high-value deals as firms defend market share and pursue workflow-enhancing AI.
Philips says the expansion of its facility in Reedsville, PA, will not only boost its capacity to produce AI-enabled ultrasounds that are used in hospitals across the US but will also create 120 well-paying jobs.