Some manufacturers are now embedding CER processes within broader regulatory operating systems, integrating authoring, ...

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has been a top priority and now, more companies are moving toward EU MDR ...

Recor Medical Announces Paradise Ultrasound Renal Denervation System Receives Manufacturing and Marketing Approval in Japan for the Treatment of Resistant Hypertension. Terumo Corporation is acquiring ...

Originally CE marked in 2021 for limited to high-risk patients only, .Abbott has now received CE mark approval for its Navitor transcatheter aortic valve replacement (TAVR) system to treat low- and ...

The physician has a unique perspective that non-clinical investors don’t: they know firsthand whether a technology will be adopted. They deeply understand if it truly is better for them and their ...

Company says the system empowers clinical teams to respond to surges, track usage and ease workflows with user-friendly touchscreen technology for telemetry patients on the move.

We stopped squeezing every last patient slot out of our clinicians. Here’s what ...

An increasing number of medical devices incorporate artificial intelligence (AI) capabilities to support therapeutic and diagnostic applications. In spite of the risks connected with this innovative ...

Infographics can propel MedTech research and campaigns and enhance the user experience. Here Fabricio Pamplona, co-founder of online infographic maker for scientists Mind the Graph, explores the power ...

In an era where sustainability is no longer a choice but a necessity, the medical industry finds itself at a crossroads. With the increasing amount of medical waste generated daily, the traditional ...

A global need for less invasive medical procedures and high efficacy treatments has outlined the developments of cardiovascular devices. Cardiovascular diseases or CVDs have long been considered among ...

A recent project conducted by Northeastern graduate students looked at device recalls over the past five years and some of the common threads. In 2018, the top causes of recalls were software, ...