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Updated SOFTWARE Act: Still Too Ambiguous For Industry?

While some industry experts say the updated version of the SOFTWARE Act strikes a tenable balance between industry's need for certainty and FDA's need to ensure patient safety, others argue it does not go far enough to explicitly state what kinds of health IT software the agency will not regulate.

While Rep. Marsha Blackburn's most recent version of the SOFTWARE Act reduces criteria FDA could consider when deciding if a health IT software should be regulated compared to previous versions it still gives the agency overarching authority to determine what health software poses higher risk to patients which has some experts conflicted over its significance.

Three days before the House Energy and Commerce Subcommittee unanimously approved the 21st Century Cures bill that includes the measure, Blackburn released a revised version of the Sensible...

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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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• By Brian Bossetta

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Bone Surgery Startup Surgify Medical Raises $7.9m

 
• By Natasha Barrow

Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.