Regulatory & Quality

The Osaka, Japan-based company gained access to the DE-128 device when it acquired Innfocus for about $225 million in 2016.

Device manufacturers of CAS systems should keep abreast of the changing legal issues.

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

CVRx's BeAT-HF study represents a major turning point in heart failure therapy and ushers in a new era for breakthrough medical devices.

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.

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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.