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Fruitful Use Of EU Reg Loopholes Or Farce? How The Cranberry Is Dividing Opinions

 
• By Amanda Maxwell

The borders between medical devices, pharmaceuticals and even nutraceuticals are so fine that many companies seek to cross these subtle lines in order to gain regulatory or marketing advantage over their competitors. Often, this is achieved with success – although sometimes on shaky ground.

The borders between medical devices, pharmaceuticals and even nutraceuticals are so fine that many companies seek to cross these subtle lines in order to gain regulatory or marketing advantage over their competitors. Often, this is achieved with success – although sometimes on shaky ground.

The latest case to come to the attention of the European Commission, Clinica understands, concerns cranberry capsules. It was brought...

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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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Philips Announces Major Investment In US Manufacturing And Expansion Of Pennsylvania Facility

 
• By Brian Bossetta

Philips says the expansion of its facility in Reedsville, PA, will not only boost its capacity to produce AI-enabled ultrasounds that are used in hospitals across the US but will also create 120 well-paying jobs.

UK’s Dementia Trials Accelerator Works To Fast-Track Trial Recruitment

 
• By Anabel Costa-Ferreira

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.

Breathing Easy: Freespira Works To Expand Access To Panic And PTSD Treatment

 
• By Elizabeth Orr

Freespira’s device has been FDA-approved to treat panic disorders and PTSD. CEO Joe Perekupka told Medtech Insight the company’s innovative approach includes patient coaching, insurance partnerships to identify potential users, and lobbying for broader insurance coverage for digital therapeutics.