1. Medtech Insight

Study: Nearly 30% Of Device Adverse Event Reports Don’t Meet Deadline

 
• By Elizabeth Orr

Data recently published in The BMJ found that almost 30% of device adverse event reports filed with the US FDA are late or missing accurate date information. A relatively small number of companies account for more than half of the late reports.

Businessman standing on a clock sinking in water. Concept: Time pressure, Deadline.
(Elnur/Shutterstock)

The US Food and Drug Administration’s ability to monitor early device safety signals may be hampered by late reporting of device adverse events, research published this week in The BMJ argues.

The study, performed by a team of researchers led by Washington University of St. Louis medical school professor Alexander Everhart,...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Medtech Insight

Ellipsis Raises $45M To Expand AI Care Manager Across Health Systems

 
• By Marion Webb

Ellipsis said it will use its new funding to expand its AI-powered voice assistant Sage across health systems. Ellipsis is part of the global vocal biomarker market, which is expected to exceed $9bn by the end of 2033, according to a research market report.

US FDA Unveils Plans To Consolidate Support Services

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 
• By Brian Bossetta

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

‘UK Must Put Adoption On A Par With Innovation’

 
• By Ashley Yeo

Market access concerns dominated at the annual BioWales In London event, where AstraZeneca set out industry’s priorities and the UK Office for Life Sciences struck an optimistic tone about how the UK will lastingly improve uptake of innovation.

More from Regulation

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel