Of the five original PMAs approved last month by US FDA, two target diabetes and one targets obesity. In addition, the agency granted a de novo classification to another obesity device. Overall, FDA had a productive third-quarter for approvals and clearances.
[Editors' note: For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out our Approvals Tracker.]
Products addressing metabolic conditions attracted the most attention from US FDA's novel device approval pathways in September.
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.
A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.
