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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.

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.

A panel of mental health experts, advocates, and patients met recently in Manhattan to discuss the promise of the Neuronetics’ NeuroStar transcranial magnetic stimulation system, which the US FDA recently cleared to treat depression in adolescents ages 15 through 21. It is the first and only treatment of its kind the regulatory agency has cleared for this patient group.

Alison Sundset heads up Holocare, a company working to transform surgical planning. Over the course of her career, she has had to train herself not to show emotions at certain times - an issue she argues would not have presented itself if she was a man.  

Introducing the all-new Citeline News and Insights app, providing seamless access to all your favorite award-winning publications. Explore the latest articles from Pink Sheet, Scrip, In Vivo, Medtech Insight, Generics Bulletin and HBW Insight, all in one stylish, intuitive and user-friendly platform.

AI voice tech start-up Canary Speech is developing algorithmic models for detecting behavioral health, progressive neurological and cognitive diseases based on a 40-second recording of speech. Medtech Insight caught up with Canary CEO Henry O’Connell at DHIS West to learn more about the company and its plans.

The seasoned regulatory attorney, who recently moved to law firm King & Spalding, spoke to Medtech Insight about his priorities, what keeps him interested in device law, and the three things manufacturers should consider when seeking a device approval.

MediGo extends CareDX’s digital product lineup while expanding its reach into the organ procurement organization market.

Renalytix president Tom Mclain outlined the company’s commercial strategy for its AI-powered blood test to detect early-stage kidney disease in patients with diabetes.

Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. Leonard Ganz, chief medical officer at Abbott’s cardiac rhythm management business, talked to Medtech Insight about the company’s new Assert-IQ insertable cardiac monitor, which offers long-term monitoring and remote programming to improve connectivity.

Brazil's ABIMO medtech industry association reports newly-buoyant levels of export activity, as normal business routines crystalize further in the post-COVID phase. Meanwhile, member companies of the Brazil Health Devices initiative are outperforming industry averages.

New survey data show manufacturers are seeking out alternate suppliers and new validation techniques to ensure a steady supply of the essential chips.

The FDA’s proposed Quality Management System Regulation (QMSR) does not say if a regulation limiting the types of reports FDA investigators can review will be kept in place, which concerns some observers – including Morgan Lewis partner Dennis Gucciardo.

Jeff Shuren, director of the US FDA’s Device Center was recently quizzed by the House health subcommittee on why the new user-fee deal had reached Congress late, among other issues. See what Shuren said about it here.

Did the White House Office of Management and Budget review the US FDA’s draft harmonized Quality System Regulation too quickly to be thorough? Ricki Chase, a former FDA-er who now works at Lachlan Consultant Services, says it's possible.

Consumer demand for masks likely won’t slow following the pandemic, DemeTECH VP Luis Arguello Jr. told Medtech Insight. 

Owlet Baby Care has stopped selling its Smart Sock baby monitoring device after a five-year fight with the US Food and Drug Administration over whether the product should be regulated as a medical device. The company is now seeking FDA clearance.

The Association for the Advancement of Medical Instrumentation’s new technical information report guides pump makers as they test their devices for clinical scenarios. See what Ben Powers, VP of infusion pumps at Ivenix who co-chairs the infusion device committee within the Association, said about it here.