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Accomplished Milestones in 2019: First Quarter: Announced completion of Engineering Confidence Build Announced publication of first peer-reviewed manuscript in Surgical Endoscopy Documented results of confidence build unit testing and implemented design improvements Began planning preliminary audit of quality system by European Notified Body Second Quarter: Updated system design and related hardware and software documentation Initiated capital equipment design freeze Initiated preclinical live animal (swine) and cadaver surgery studies under GLP protocols Upcoming milestones for 2019: Third Quarter: Complete and document preclinical live animal (swine) and cadaver surgery studies Verify production system operation with clinical experts under rigorous formal human factors evaluation under simulated robotic manipulation exercises Submit Investigational Device Exemption (IDE) application to FDA Obtain ISO 13485 Certification Receive IDE approval from FDA Fourth Quarter: Complete and document human confirmatory studies performed under IDE Submit technical file to European Notified Body for review for CE mark Submit 510(k) application to FDA Titans Leadership Team : David McNally, an executive who has successfully created and developed two medical device companies while generating significant shareholder value joined Titan as the CEO in 2017

Users engaging in long-term use should implement regular monitoring through comprehensive health assessments and laboratory testing

Patients should follow the advice of their bariatric team regarding their particular monitoring plan

Nature Metabolism

[DOI] [PubMed] [Google Scholar] De Jager 2010 Jager J, Kooy A, Lehert P, Wulffel MG, Kolk J, Bets D, et al

What follows reflects the current evidence base honestly