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Long Road To Unique Device Identification: FDA’s ‘Mr. UDI’ Offers Peek Behind Curtain

 
• By Shawn M. Schmitt

The man who coined the term “Unique Device Identification,” Jay Crowley, opens up in an interview about hurdles FDA faced in setting up the system; anxiety he felt when Congress set a deadline for the final rule to be published; and why he believes UDI would have eventually happened organically anyway, among other UDI-related topics. “Sometimes people call me Mr. UDI … I think that name might stick for a while,” jokes Crowley, who planted seeds in 2002 for FDA’s new regulation to track and trace products. Since then it has mushroomed into an emerging program that has the backing of a majority in industry.

When FDA released its final Unique Device Identification rule in late September, tongues wagged. Manufacturers scrambled to determine how they would be affected. Attorneys and consultants pored over every word in the 160-page document.

And the principle architect of the UDI program, Jay Crowley, heaved a sigh of relief and reflected on an initiative nearly a dozen years in the making.

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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.

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Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.