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BMJ editorial argues for combining device reports with registries

A BMJ editorial argues that FDA adverse-event reports can flag medical-device safety concerns, while clinical registries help measure risk. It cites a cross-sectional study that found frequent errors and delays in MAUDE summary reports.

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FDA approves an expandable pulmonary valve for children

The FDA approved the Autus Size-Adjustable Valve for children with congenital pulmonary valve disease. It can be widened after implantation as a child grows, though longer-term studies are still underway.

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SpiraMed Uses a Helical Catheter to Deliver Therapies in the Brain

A bioRxiv preprint describes SpiraMed, a helical catheter designed to deliver therapies across a brain target through one access path per target. Testing in phantoms, sheep and cadaveric human brain reported improved coverage and reduced reflux, but the work is preclinical.