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IMDRF Tackles Confusion Over Clinical Evidence Expectations for Device Software

 
• By Neena Brizmohun

If all goes to plan, the International Medical Device Regulators Forum will have completed by July a draft guidance that explores when and to what level clinical evaluation and evidence is necessary or acceptable to support marketing authorizations of software as a medical device (SaMD)1.

If all goes to plan, the International Medical Device Regulators Forum will have completed by July a draft guidance that explores when and to what level clinical evaluation and evidence is necessary or acceptable to support marketing authorizations of software as a medical device (SaMD)1.

The draft document is being developed to address the current confusion over – and the lack of guidance on – what clinical data is appropriate for the uniqueness of medical...

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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.

More from Medtech Insight

Siemens Healthineers Widens FY25 EPS Range By €0.15 To Absorb Up To €300M In Tariff Costs

 
• By Shubham Singh

The imaging, Varian, and advanced therapies segments – which are more reliant on equipment sales – are more heavily affected, with tariffs applying to roughly 55% of their revenue base. In diagnostics, the company expects minimal exposure due to sufficient US value-added manufacturing.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
• By Marion Webb

Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.