Regulatory & Quality

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In March, NeuroMetrix and its CEO agreed to pay nearly $4 million to FTC for the refunds and the company agreed to stop making the allegedly deceptive claims about the pain relief device.

The Marlborough, MA-based company has received CE mark for the fourth generation Vercise Genus Deep Brain Stimulation System.

FDA is building a web-based tracker that displays the progress of a medical device marketing submission throughout the agency's review process. The agency is seeking industry feedback on the features and information medical device companies would...

Pressed for time? Here's the medtech news you need most, in one minute or less.

The liquid biopsy specialist said its test was based on analytical and clinical validation studies that included more than 7,500 samples and 30,000 unique variants across over 30 cancer types.