MedTech Intelligence Industry Survey Research Methodology

By MedTech Intelligence Staff

The MedTech Intelligence Industry Survey is a primary research initiative designed to capture the perspectives of professionals working across the medical technology sector. The study is intended to examine the pressures, priorities, technology shifts, operational challenges, and strategic changes influencing MedTech organizations in 2026.

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Devices are Getting Smarter, Making Materiovigilance Evolve Faster

By Dr. Padmalakshmi Jnaneshwar

According to Deloitte, only 22% of life sciences leaders say they have successfully scaled AI, and just 9% report achieving significant returns. For materiovigilance, this highlights the growing gap between execution and team expectations. Within this gap, fragmented data and manual processes continue to slow response times and increase compliance risk, creating a disconnect between the promise of real-time safety monitoring and operational reality. How can organizations close this execution gap and evolve materiovigilance from a reactive compliance function into a proactive, data-driven discipline?

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Balancing Cyber Risk
Balancing Cyber Risk

What 524B and QMSR Change About Medical Device Risk

By Kaleb Averell

What 524B and QMSR actually require, in plain terms, including the post-market obligation that does not end at clearance? How both map to four kinds of exposure: cybersecurity, product liability, recall, and management liability. Where device makers are commonly unprepared against the new baseline, including the gap between cyber risk and product liability for software and devices.

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CMS Proposes TAVR Medicare Coverage is Potential Boost for Edwards Lifesciences

By MedTech Intelligence Staff

CMS’s proposed expansion of Medicare TAVR coverage to include select asymptomatic severe aortic stenosis patients and reduce access barriers for symptomatic patients could significantly increase TAVR adoption, creating a growth opportunity for Edwards Lifesciences through expanded eligibility, higher procedure volumes, and continued leadership in structural heart care.

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Medtronic Logo
Medtronic Logo

Medtronic Advances Hugo Robotic Surgery Platform with Key FDA Filings and Product Approvals

By MedTech Intelligence Staff

Medtronic announced several regulatory milestones for its Hugo robotic-assisted surgery platform, including FDA submissions for general and gynecologic surgery indications and the LigaSure™ RAS instrument, alongside FDA clearance for its ProGrip™ Advanced hernia mesh. The developments expand the company’s robotic surgery portfolio and support its growth strategy in minimally invasive surgical care.

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