Cures Act

21st Century Cures Act Spurs Medical Device Opportunities

The 21st Century Cures Act (the Cures Act) includes many significant changes to the regulatory landscape for medical devices. Signed into law by former President Barack Obama on December 13, 2016, with overwhelming support in the House (392-26) and Senate … Read More

rescue study

When it’s time to rescue a study

Planning and executing a global, interventional medical device study is a complex process. Whether you’re managing the study internally or partnering with a qualified CRO, there are times when studies may not go as planned. If multiple problems arise that … Read More

TMVR

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

Clinical Evaluation Report (CER)

Revision 4 Clarifies the Clinical Evaluation Report (CER)

Clinical Evaluation: MEDDEV 2.7/1 Revision 4 A new guidance document for Clinical Evaluation (MEDDEV 2.7/1 Rev. 4) was released this summer providing new requirements and much-needed clarification in several areas. The new guidance offers clarity around writing a fully compliant … 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

Medical Device Development

Medical Device Development: Distinctions Matter in Clinical Studies

Developing medical device clinical trials for investigational Class II or Class III devices typically means planning around a lot of moving parts that aren’t normally factors in drug studies. Devices are often engineered to have multiple components—hardware, software and/or medicinal … 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