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FDA makes the Boston Scientific Imager II removal a Class I recall Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical Microbot Medical puts Liberty in 12 sales territories and targets positive gross margin in 2027 NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 FDA drafts surgical robot testing expectations and leaves autonomy out of scope Marani Health clears the M•care system for fetal and maternal monitoring at home FDA books December 2 and 3 for a workshop on robot autonomy and remote teleoperation Biolinq clears Shine for over-the-counter sale a year after its De Novo FDA makes the Boston Scientific Imager II removal a Class I recall Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical Microbot Medical puts Liberty in 12 sales territories and targets positive gross margin in 2027 NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 FDA drafts surgical robot testing expectations and leaves autonomy out of scope Marani Health clears the M•care system for fetal and maternal monitoring at home FDA books December 2 and 3 for a workshop on robot autonomy and remote teleoperation Biolinq clears Shine for over-the-counter sale a year after its De Novo

The Directory / GI & Urology

GI & Urology

EvoEndo

Denver, CO · Unknown · 510(k) cleared

Makes a single-use gastroscope for upper endoscopy through the nose without general anesthesia or conscious sedation, in adults and children.

FDA DECISIONS ON FILE

2 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Apr 21, 26	K260573510(k)	EvoEndo Single-Use Endoscopy System	EvoEndo, Inc.	Gastroenterology, Urology	FDS
Oct 10, 25	K251708510(k)	EvoEndo Single-Use Endoscopy System	EvoEndo, Inc.	Gastroenterology, Urology	FDS

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