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What Makes The Ideal Registry? Focus, Transparency, Versatility, Groups Say

A report from Pew, the Blue Cross Blue Shield Association and Cornell researchers argues that a stronger system of medical device registries is needed in the U.S., but it also readily acknowledges the limits of registries and, in particular, the fact that they can be very resource intensive.

Registries are not for every device, but when they are warranted, they should be tightly focused and very transparent, according to Sept. 3 recommendations from groups closely engaged in FDA’s efforts to upgrade the U.S. postmarket device surveillance system.

The report from the Pew Charitable Trusts, the Blue Cross Blue Shield Association and Cornell University researchers, argues that the...

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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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Roche Diagnostics Growth Flattens As China Reforms Bite; Bets On US Manufacturing, CGM For Growth

 
• By Shubham Singh

Roche has taken steps to mitigate potential tariff exposure that include shifting inventories and increasing US production of medicines. The company also initiated a tech transfer for one of its most exposed products to a US manufacturing site.

Award-Winning Lioness Implant Addresses ‘Silent Emergency’ Of Preterm Birth

 
• By Ashley Yeo

The Lioness non-surgical silicon ring implant is designed to put an end to pre-term births, sparing maternal anguish and saving health system costs. PregnanTech won the Biomed Israel 2025 medtech start-up award, and Limor Sandach told In Vivo how a non-digital technology beat off stiff competition.

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.