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Archive for the 'Medical Device Trends' Category

Possible exemption of 337 devices from FDA 510k requirements

Posted on March 21st, 2017 · Posted in FDA Regulatory Updates, Medical Device Trends

FDA is considering the following list of devices as exempt from 510k requirements. The agency continues to emphasize that Class II devices exempt from 510(k) requirements must still meet other US regulatory.. read more

jaw print

3D medical and bio-printing. Get ready, this technology is no longer the future.

Posted on November 19th, 2014 · Posted in Medical Device Trends

Over the last 10 years the 3D printing industry has changed dramatically. As materials and printing technologies have advanced, the shift into printing products for the human body has made.. read more

doctor ipad

Mobile medical apps are changing our health care system; rapidly and drastically.

Posted on December 30th, 2013 · Posted in Medical Device Trends

Did you know, the FDA cleared over 100 medical apps in the last 10 years? 40 of these apps were cleared in just the last 2 years. The medical app.. read more

Image courtesy of sculpteo.com (printing the human body)

How will the FDA regulate 3D printing and rapid prototyping?

Posted on October 6th, 2013 · Posted in Medical Device Trends

As biotechnology continues to advance into the areas of cellular printing, it is becoming ever more difficult for the FDA to determine how these machines and the produced products will.. read more