MedTech Global Insights

This week on MedTech Global Insights, we dissect a major strategic win in the cardiovascular space. Abbott's recent dual-market approval for its AI-powered imaging software in both the U.S. and Europe is more than just...

The US FDA's 510(k) pathway has fundamentally changed in 2026. What was once a straightforward process for many devices has now evolved with complex new requirements for cybersecurity and the use of Real-World Evidence...

The U.S. FDA has just released transformative new guidance on medical device cybersecurity, moving it from a final-stage checklist to a core requirement throughout the entire product lifecycle. This shift demands a...

In this episode, we dissect the groundbreaking new program from the FDA and CMS that bridges the gap between regulatory approval and Medicare reimbursement in the United. States. This policy shift is set to eliminate...

This week, MedTech Global Insights tackles the monumental shift in the U.S. regulatory landscape: the new Quality Management System Regulation (QMSR). While the FDA’s alignment with ISO 13485 promises global harmony, we...

This week, we dive into the groundbreaking joint guidance on AI/ML medical devices recently released by US and EU regulators. This new framework for Predetermined Change Control Plans (PCCPs) promises to accelerate...

Last week, the US FDA and CMS announced the TCET pathway, a landmark program to accelerate insurance coverage for innovative medical devices. This move aims to eliminate the notorious "valley of death" where approved...

This week, we dissect the major regulatory shift in Singapore, as the Health Sciences Authority (HSA) releases groundbreaking new guidance for AI and Machine Learning medical devices. This move tightens the rules on...

Last week, the European MedTech landscape was thrown into chaos. A major Notified Body was suddenly delisted, leaving hundreds of device manufacturers with invalid CE marks and effectively halting their market access...

In this episode, we dissect the FDA's monumental decision to regulate Laboratory Developed Tests (LDTs) as medical devices, ending a long-standing policy of enforcement discretion. We explore what this regulatory shift...

This episode of MedTech Global Insights unpacks the massive $13.1 billion acquisition of Shockwave Medical by Johnson & Johnson. We explore the groundbreaking sound-wave technology that made Shockwave a prime target and...

This week, MedTech Global Insights dives into the sudden regulatory shift from the UK's MHRA, which has enforced a new, stricter framework for AI medical devices. This unexpected announcement creates significant hurdles...

This week on MedTech Global Insights, we dissect the major announcement of a new regulatory alignment between the UK's MHRA and the US FDA. This move could potentially reshape market access strategies for medical device...

This week, we dive into the most significant shift in U.S. MedTech regulations in years: the FDA's new Quality Management System Regulation (QMSR). While it harmonizes with the global ISO 13485 standard, manufacturers...

This week, we dissect the groundbreaking FDA approval of a first-of-its-kind device for pancreatic cancer. This new technology, which combines focused ultrasound with AI targeting, offers new hope for patients but also...