Regulatory & Quality

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?

It’s exciting to start a company with a new medical device. Don’t let that excitement get in the way of planning.

Invitae is set to acquire Boulder, CO-based ArcherDx in a deal valued at $1.4 billion. As a result of the news, shares of Invitae soared on Tuesday.

The Dublin-based company said it has received CE mark for an expanded indication of its Evolut Transcatheter Aortic Valve Implantation system to treat patients with severe native aortic stenosis who are at a low risk of surgical mortality.

FDA said it enacted this measure because there were performance concerns with the accuracy of the test.

The study is set to evaluate POSE 2.0, an incisionless weight loss procedure.

FDA is trying to make it easier to bring COVID-19 testing to the market as a screening tool for asymptomatic people and for sample pooling.