Regulations

End-user surveys offer a cost-effective approach for assembling evidence for post-market clinical follow-up.

The device is part of the Carlsbad, CA-based company’s MIS Ultra Suite of products.

As medical device companies use the extra time to respond to the COVID-19 pandemic, what efforts could continue to ensure MDR compliance by May 2021?

The Cambridge, MA-based company has won approval from FDA for FoundationOne CDx to work as a companion diagnostic alongside Merck’s KEYTRUDA (pembrolizumab), an anti-PD-1 therapy.

Experts speaking at MD&M West offered strategies for preparing for the European Union's Medical Device Regulation.

Medtech companies offering cloud-based services should carefully examine their technologies for potential patentable inventions prior to offering services to others.

The medical device tax was introduced in 2013 as part of the Affordable Care Act. Those who oppose the tax have been highly-vocal about the impact it could have on the industry.