1. Medtech Insight
  2. >>Archive

FDA’s Latest Post-Market Plan: Data-Mining Device Safety … And Then There’s MAUDE

 
• By Shawn M. Schmitt

Data-mining software tools will be used by FDA to find troubling patterns with particular devices as part of the agency’s latest plan to beef up its post-market surveillance activities. However, “we haven’t determined the device areas in which we will implement data-mining,” CDRH Chief Scientist William Maisel said. Meanwhile, a new system will be piloted to replace the MAUDE adverse event database, and CDRH Director Jeffrey Shuren explains why Unique Device Identification and product registries will play an important role in the new post-market plan.

FDA is putting finishing touches on data-mining software tools that will flag high-quality adverse event reports and pinpoint percolating problems in specific devices. But the agency has yet to pick product types that will first be targeted with the new tools.

Software algorithms will “focus in on adverse event reports that are the most complete and have the information we need...

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 Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

More from Medtech Insight

Ochsner Surgeon In ‘The Big Easy’ Eases Patient’s Pain With Skill And Virtual Reality

 
• By Brian Bossetta

A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.

Execs On The Move: June 30–July 4, 2025

 
• By Medtech Insight Team

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By Elizabeth Orr

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.