Medtech Insight - News And Expert Analysis For Medtech Decision Makers since 1975

Medical devices, diagnostics, and equipment face tariffs announced by President Donald Trump, despite industry pleas for exemption. The tariffs, ranging from 10%-49%, impact most countries trading with the US, potentially hindering innovation and increasing costs in the medtech sector.

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.

Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.

A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Cybersecurity, sustainability and regulatory intelligence all need factoring into risk management today as AI and data availability change the goalposts. Eight experts tell Medtech Insight how compliance efforts must adapt.

In an interview with Medtech Insight, Dexcom’s COO Jake Leach and Adrian Gut, senior director international access, discuss the company’s global expansion, the role of AI in diabetes management, the challenges of securing reimbursement, and how regulators are influencing the future of CGM technology.

Vektor Medical is ramping up efforts to bring its vMap technology used to identify arrhythmia sources to more US hospitals, start enrollment in a multinational trial, and commercialize in Europe, pending the CE mark. Medtech Insight sat down with CEO Rob Krummen at LSI 2025 to discuss their plans.

People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.

AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.

Abbott presented late-breaking data at the 2025 American College of Cardiology conference demonstrating that TriClip transcatheter edge-to-edge repair offers prolonged patient benefits compared to medical treatment alone after two years, which were not evident at one year.