Regulatory & Quality

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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.

Critics of the potential therapy for COVID-19 patients urged FDA to hold off on Emergency Use Authorization.

Join News Editor Amanda Pedersen on Tuesday via Facebook Live for a candid discussion about President Trump's attempt to bar FDA from regulating laboratory tests. The Medtech Unfiltered live stream will begin at 8 a.m. PST / 11 a.m. EST.

The move comes as FDA has put a potential pause on an EUA for convalescent plasma – a therapy President Trump has championed - to treat COVID-19.

While some believe cutting ties with China would serve as an impetus for more goods to be made in America, some medtech leaders think it could be disastrous — especially during a pandemic.

Join News Editor Amanda Pedersen on Tuesday via Facebook Live for a candid discussion about the ongoing trade war between the United States and China, and how it impacts the global medical device supply chain. The Medtech Unfiltered live stream...

FDA provided a list of medical device shortages during the ongoing COVID-19 pandemic.