US FDA statistics shared with Medtech Insight show that the number of Medical Device Reports sent to the agency dramatically rose last year, both in individual and summary formats. Might the agency's upcoming Voluntary Malfunction Summary Reporting Program slow the overall number of MDRs this year?
Device-users and companies had the dubious distinction of making history last year by sending the largest number of Medical Device Reports ever – nearly 1.5 million – to US FDA.
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Ireland’s NSAI reinstated under IVD Regulation designation list
The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.
Abbott and J&J reassured investors they will maintain their 2025 profit forecasts. Abbott projects $5.05 to $5.25 per share and plans a new $500m investment in manufacturing and R&D sites. J&J anticipates $400m in tariff-related costs but committed $55bn in US investment over four years.
Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?
Precision’s recent FDA clearance for a core part of its next-generation wireless brain-computer interface system opens the pathway to a safer, more humane BCI for researchers to use compared to higher-risk intracortical arrays, according to BCI expert Naveen Rao.
The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.
Abbott and J&J reassured investors they will maintain their 2025 profit forecasts. Abbott projects $5.05 to $5.25 per share and plans a new $500m investment in manufacturing and R&D sites. J&J anticipates $400m in tariff-related costs but committed $55bn in US investment over four years.
