1. Medtech Insight
  2. >>Archive

US FDA pilot aims for 30-day review of 510(k)s submissions for IVDs, radiology devices

 
• By Vibha Sharma

The US Food and Drug Administration has launched a six-month pilot programme under which it will aim to issue decisions on certain "good quality" pre-market notification (510(k)) submissions within 30 days, rather than its current standard of 90 days1.

The US Food and Drug Administration has launched a six-month pilot programme under which it will aim to issue decisions on certain "good quality" pre-market notification (510(k)) submissions within 30 days, rather than its current standard of 90 days1.

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

Deals Shaping The Medtech And Diagnostics Industries, March 2025

 
• By Medtech Insight Team

An interactive look at medtech and diagnostics deals made during March 2025. Data courtesy of Biomedtracker.

Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

 
• By Natasha Barrow

“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.

MedStar Teams Up With Reimagine Care To Extend Cancer Care Into Patients’ Home

 
• By Marion Webb

Reimagine Care teamed up with MedStar Health to support cancer patients at home via an AI assistant and clinical support. Reimagine Care’s data suggests its platform can save cancer centers up to $1m annually per full-time oncologist panel and reduce ED visits by 30%.