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FDA Announces Updates to “Refuse to Accept Policy”

7 questions to ask before submitting 501(k)

The FDA recently issued updates to its guidance for its “Refuse to Accept Policy for 510(k)s” for Center for Biologics Evaluation and Research-regulated (CBER) devices and for “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs).”

What You Missed Last Month February Edition (3D Printing)

February was a lovely month and has passed quickly as we celebrated Valentine’s Day and continued to work hard on our New Year resolutions. In case you haven’t had the chance to catch up, here is what happened last month in 3D printing and the Medical Device Industry.

Market Researchers See Double-digit Growth in 3D Medical Device Market

The global market for 3D printed medical devices is poised for rapid growth according to a new market research report by Transparency Market Research.

The firm says the 3D printed medical device market will expand at a compound annual growth rate (CAGR) of 17.7 percent over the next 8 years, rising in value from $713 million in 2016 to $3.5 billion by 2025.

Using 3D Printed Parts To Make Low-cost Live-cell Imaging Microscope

3D printing doesn’t always have to be used for new, high-tech applications such as printing tailor-made medical devices. Researchers at Uppsala University have used 3D printing to create an inexpensive tool to make live image videos of living cells.

What You Missed Last Month January Edition (3D Printing & Cybersecurity)

Lots has happened in the MedTech Industry in the beginning of the New Year! The FDA has made statements concerning the future of 3D printing in medicine as well as provided recommendations for medical device cybersecurity, which has become an increasingly popular topic in healthcare. Take a quick look at what you missed in the month of January:

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