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Resources for the Start-Up Medical Device Company

Latest News & Insights

September 14, 2023

FDA Releases Draft Guidances on 510(k) Submissions

On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing...
September 7, 2023

Medtronic Sued for Allegedly Sharing Health Info with Google

Medtronic Minimed, Inc. and Minimed Distribution Corp. (“Medtronic”) were sued in a class action complaint in the Central District of California on August 30, 2023, by users of Medtronic’s InPen®...
September 6, 2023

FDA Issues Updated Informed Consent Guidance for Clinical Investigations

On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations.  The FDA’s updated guidance is titled Informed Consent Guidance for...
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Upcoming Events

Sep 18 - 22, 2023
The Ritz-Carlton Barcelona, Spain
LSI

LSI Europe 2023 – Emerging MedTech Summit Opens in new window

The summit provides a streamlined platform and companion with industry leaders, potential strategic partners, investors, and peers in MedTech innovation.
Sep 21 2023
AV Irvine Irvine, CA
Octane

High Tech Awards (HTA) Opens in new window

HTA seeks to celebrate and recognize those individuals and companies who make Orange County a center of technology and medical technology innovation.
Sep 27 2023
Phoenix Convention Center Phoenix, AZ
AZBio

2023 AZBio Special Supplement and Awards Opens in new window

An awards event celebrating educators, researchers, and organizations in the life science field.
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