Endoscopy Devices
Flexible and rigid scopes plus accessories used for visualization, diagnosis, and therapy inside the GI tract, airways, urinary tract, and joints.
Definition
The endoscopy segment covers flexible video gastroscopes, colonoscopes, duodenoscopes, bronchoscopes, ureteroscopes, and rigid arthroscopes, together with the light sources, processors, capnography, insufflators, and single-use accessories (snares, biopsy forceps, hemoclips) that complete a procedure. The market splits between reusable scopes (capital + reprocessing) and a fast-growing single-use segment driven by infection-control concerns following duodenoscope-associated CRE outbreaks (FDA 2015-2019 safety communications).What this means in practice
Single-use scopes (Ambu, Boston Scientific Exalt) and disposable elevator caps reset the segment's economics. AI-assisted polyp detection (CADe) is now a major sub-segment with multiple FDA-cleared products (e.g., GI Genius, Endoscreener).- •Underestimating reprocessing validation requirements, FDA expects multi-cycle worst-case soiling validation.
- •Treating an AI overlay as a feature rather than a separate SaMD requiring its own clearance.
- •Ignoring FDA 522 post-market surveillance orders applicable to duodenoscopes.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsA device the original manufacturer labels for one use or one patient, distinct from reusable devices and from FDA-regulated reprocessed SUDs.
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Activities to monitor device safety and performance after market release.
Software intended for medical purposes that performs without being part of a hardware device.
More in Market Segments
· Same categoryLasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions.
Software that analyzes medical images to triage, detect, or quantify disease.
Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors.
Devices for diagnosing, monitoring, or treating cardiovascular disease.
Primary references
3 sources- 1
FDA, Duodenoscope ReprocessingVerifiedFDAfda.gov
- 2
21 CFR 876 Gastroenterology-Urology DevicesVerifiedeCFRecfr.gov
- 3
MedTech DiveVerifiedMedTech Divemedtechdive.com
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