Overcoming Obstacles to TMVR Device Approval

I recently contributed an article and perspective for MD+DI regarding challenges ahead for TMVR, or transcatheter mitral valve replacement. Although the technology has not seen the rapid clinical success and adoption of its cardiological cousin, TAVR, or transcatheter aortic valve … Read More

TAVR procedure

TAVR Procedure: Clinical Studies Keeping Pace with Innovation

Those of us who attended EuroPCR 2016 may recall the discussion between cardiologists and cardiac surgeons regarding whether or not transcatheter aortic valve replacement (TAVR) should be used in lower surgical risk patients. Generally, the cardiologists gave the procedural intervention … Read More

bioresorbable stent

Bioresorbable Stent Success Bodes Well for US Market

Cardiovascular medicine will see big changes as bioresorbable scaffolds emerge onto the US market. These scaffolds degrade naturally in the body rather than remain as permanent hardware, yet they promise the same medical benefits as conventional metal stents. The next … Read More

How to Speed Device Reviews without an Accelerated Pathway

The U.S. Food & Drug Administration (FDA) recently launched the Expedited Access Program (EAP), which now allows device and diagnostics developers to reap the benefits of an accelerated pathway. While this is welcome news for the device and diagnostics companies … Read More

Medical Device Trials Find New Home in Asia Pacific

With increasing pressure to reduce manufacturing costs, increased regulatory scrutiny and the need to accelerate time-to-market, we are finding many device and diagnostics companies striving to expand clinical trial operations to emerging markets – most notably Asia Pacific. In our … Read More

A Glimpse into the Medtech Industry in 2020

The medical device and diagnostics industry has seen strong growth in recent years. This has been recognized in the number of new technologies under research and development (R&D), the significant uptick in submissions and reviews across global agencies and, as … Read More