Skip to main content
 

Fitbit is One Step Closer to Being a Health Company

In September, the U.S. Food and Drug Administration (FDA) announced that fitness tracker manufacturer Fitbit (NYSE:FIT) and eight other companies would be part of a new digital health software precertification pilot program aimed at fostering innovation and streamlining the process of getting regulated products to market. This could be good news for Fitbit. Let’s take a look at why.

Partnering with the tech industry to design a robust precertification process is a new approach that will certify a company rather than the FDA reviewing each individual product. The idea is that companies that meet certain criteria could release software-as-a-medical-device (SaMD) products with an accelerated review process or directly to market depending on the risk of the product.

Continue reading at: https://www.fool.com/investing/2017/11/09/fitbit-is-one-step-closer-to-being-a-health-compan.aspx

More News

  • Why Do the Principals of Cardeation Capital Think Joining Forces Makes Sense for Innovation?

    Click the link below to listen: Medtech Talk Podcast hosted by Tom…

  • The American Heart Association’s Innovative Solution Personalizes Cardiovascular Condition Management With Tailored Engagement to Improve Population Wellness and Reduce Readmissions

    DALLAS, April 9, 2018 /PRNewswire-USNewswire/ -- Patients battling cardiovascular diseases, and even people hoping…

  • Data Science Drives Education and Insights to People with Diabetes and High Blood Pressure

    Livongo Joins American Heart Association’s Center for Health Technology and Innovation to…

  • GoMo Health Teams Up with the American Heart Association to Beat Cardiovascular Disease

    GoMo Health is excited to announce that we are joining the American…

Sign up for our mailing list