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Navigating FDA Clearance and Launching a Medical Device with Dr. Heather Underwood of EvoEndo
Navigating FDA Clearance and Launching a Medical Device with Dr. Heather Underwood of EvoEndo
ratings:
Length:
16 minutes
Released:
Jun 16, 2022
Format:
Podcast episode
Description
Today we’re catching up with Dr. Heather Underwood, CEO of EvoEndo. EvoEndo recently completed an $8.4 million Series A financing round on the heels of 510(k) FDA clearance in early 2022. We first spoke with Dr. Underwood in June of 2021. In this episode, we chart a course through her accomplishments, lessons learned through the FDA clearance process, working with CROs, and hear firsthand about the challenges she’s tackled as Chief Executive of a medical device startup ready to revolutionize clinical endoscopy practice with a safer, faster, cost-effective alternative. About EvoEndoEvoEndo, founded in 2017 by Dr. Joel Friedlander (Chief Medical Officer), is making unsedated transnasal endoscopy a reality. General anesthesia has been the standard of care for pediatric patients undergoing endoscopies. This can be a traumatic experience, especially for patients with chronic health conditions who may require the procedure several times a year. But EvoEndo’s single-use small-diameter device for unsedated transnasal endoscopy is ready to transform this medical necessity. The company received 510(K) clearance from the FDA in February of 2022 and is poised for a commercial launch of its innovative product. About Dr. Heather UnderwoodDr. Heather Underwood joined EvoEndo as CEO in 2019 after completing the Stanford Biodesign Innovation Fellowship for medical devices. Dr. Underwood completed her Ph.D. at the University of Colorado Boulder's ATLAS program where she developed and implemented clinical decision support systems for midwives and nurses in Kenya, receiving the NSF Graduate Research Fellowship grant and a Gates Grand Challenges grant to support her research. She has spent the last 10 years founding and leading medical device startups, non-profit life science organizations, and innovative academic initiatives. LinksHeather Underwood | LinkedIn:https://www.linkedin.com/in/hmunderwood/ EvoEndo:https://evoendo.com/Titan100:https://www.titan100.biz/2022coloradotitan100Proxima CRO:https://www.proximacro.com/Qualio website:https://www.qualio.com/Previous episodes:https://www.qualio.com/from-lab-to-launch-podcastApply to be on the show:https://forms.gle/uUH2YtCFxJHrVGeL8Music by keldez Qualio website:https://www.qualio.com/ Previous episodes:https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show:https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
Released:
Jun 16, 2022
Format:
Podcast episode
Titles in the series (97)
Trailer by From Lab to Launch by Qualio