Market Intelligence

Financings, M&A and alliances across the medical device, diagnostics and digital health sectors. Data derived from Citeline’s Meddevicetracker.

Comprehensively tracks regulatory guidance documents issued by medtech authorities worldwide. Updated monthly.

Devices granted De Novo marketing authorization by the US FDA. Data derived from FDA.gov Updated weekly.

Details and status updates on devices that have been accepted into the US Food and Drug Administration’s Breakthrough Devices program, based on company announcements and media coverage. Updated biweekly.

PMA supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.

Mergers and acquisitions in the medical device, diagnostics and digital health sectors. Data derived from Citeline’s Meddevicetracker.

Devices authorized for marketing outside the US. Data derived from Citeline’s Meddevicetracker. Updated weekly.

A comprehensive listing of FDA warning letters since 2016, sortable by CFR citation number. Updated monthly.

Devices cleared for market via US FDA’s 510(k) pathway. Data derived from FDA.gov. Updated weekly.

Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.

A scale-up strategy is the missing link in the UK devices industry, claims business research organization CPI. Own brand and contract medical manufacturer and packaging company Pennine Healthcare, and longstanding medical device CDMO Renfrew Group International, give their take on the environment for manufacturers and the opportunities for strengthening the industry base.

Global medtechs had a big enough challenge with COVID-19 and its aftermath before the full-scale regional conflict in Ukraine added more uncertainty to the question of when market normality would return.

With many medtechs restructuring for core growth in the post-pandemic era, Abbott relied on organic growth in 2022 to move to the top of the global medtech ranking. The strength of the US dollar was not kind to companies reporting in local currencies on converting revenues to dollars.

Compliance with greenhouse gas reduction targets is not optional for medtech businesses who, besides the bigger picture, have their own sustainability to think of. Environmental demands, the evolution of care models, new delivery technologies and AI tools are influencing how medtechs must approach innovation. In the EU, the MDR is also having an effect on innovation strategies.

The latest MT100 listings are now published on Medtech Insight.

Edwards Lifesciences CEO Mike Mussallem has a unique and long-standing perspective of what the medtech industry should be and do. In over two decades, he has built the structural heart disease and critical care monitoring company into one of the global medtech industry’s most effective innovators. That legacy is sure to last after his retirement as CEO in spring 2023.  

A typical word cloud for discussions around patient-centered care would feature: business model, digital health, financing, PPP, resources, data sharing, staffing and escalation of costs. But so many other words are missing, which is why patient-centricity risks getting stuck in its current incomplete form. What are medtechs to do?  

Originally intended to increase medical device safety, the implementation of the EU’s medtech regulation was so hampered in 2022 that it had started to look as if the new regulations were a bigger potential threat to patients than any of the scandals leading to its more stringent requirements. With the European Commission’s latest plans to ease challenges around implementation, will 2023 be a more positive year for the EU medtech sector?

Medtech Insight’s annual listing of the leading medtech companies by revenues is now available on the Medtech Insight website.