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Canada Sets Jan 2019 Deadline For Mandatory Adoption Of MDSAP Within Medtech Framework

 
• By Vibha Sharma

As of January 2017, medical device manufacturers selling their products in Canada will get two years to comply with the requirements of the Medical Device Single Audit Program. Specifically, after January 2019 MDSAP will become the sole mechanism to demonstrate compliance with Canadian quality management system requirements1.

As of January 2017, medical device manufacturers selling their products in Canada will get two years to comply with the requirements of the Medical Device Single Audit Program. Specifically, after January 2019 MDSAP will become the sole mechanism to demonstrate compliance with Canadian quality management system requirements1.

MDSAP is a voluntary project launched by the International Medical Device Regulators Forum and is currently in pilot phase

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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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Beyond The Bladder: Incontinence Impacts Mental Health

 
• By Brian Bossetta

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.

AI Rollout Aims To Accelerate FDA’s Product Review Process

 
• By Elizabeth Orr

The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.

Access To Library Tools Being Restored At US FDA

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals and laid off librarians have not been reinstated.