The Pocket Colposcope is a handheld microscope and imaging device for the cervix developed by biomedical researchers at Duke University and 3rd Stone Design.
Distributors / Implementing Organizations
This product is currently in the prototyping phase and not yet manufactured at scale.
Intellectural Property Type
User Provision Model
The designers have not yet selected their user provision model.
Distributions to Date Status
75% of standard-of-care colposcope
Indispensable equipment for function (Y/N)
Maintenance or calibration required by user at time of use? (Y/N)
Number of Tests Performed
Over 20,000 tests performed
Power supply type: Continuous, Recharging only (V, time required, battery life), Other
Time required for procedure (minutes)
Pocket colposcope is consist of a probe, USB cord, camera, light, focus slider, and shutter button. The product weighs less than 1 kg. The device enables healthcare providers to optically zoom in and capture acetic acid, Lugol’s iodine, and vascular images (green light imaging) by pressing a button with their thumb. Images taken with the Pocket Colposcope are transmitted instantly to a smartphone, tablet, or laptop.
Provided by manufacturer
Replaceable components include the probe of the product.
Manufacturer Specified Performance Parameters
Designer specified performance targets include: lightweight, portable, and low-cost.
Vetted Performance Status
The level of agreement between the Pocket Colposcope and the standard-of-care colposcope was 75.0% (kappa = 0.4000, p = 0.0028, n = 24).
Potential hazards related to the operation of this product include hygiene and electric leakage.
Complementary Technical Systems
Academic Research and References
Christopher, T., Marlee, S., Jennifer, E., et al., 2015, Design of a Novel Low Cost Point of Care Tampon (POCkeT) Colposcope for Use in Resource Limited Settings. Plos One.
Mercy, N., Anish, S., Usamah, C., et al., 2018, Development of Algorithms for Automated Detection of Cervical Pre-Cancers With a Low-Cost, Point-of-Care, Pocket Colposcope. IEEE, pp. 2306-2318.
Jenna, L., Elizbeth, A., Christoper, T., et al., 2017, International Image Concordance Study to Compare a Point of Care Tampon Colposcope to a Standard-of-Care Colposcope. HHS Public Access, 21, pp. 112-119.
Compliance with regulations
The product is certified by US FDA and complies to standards for colposcope. The regulation and testing includes electrical safety and essential performance requirements, electromagnetic compatibility, software verification and validation testing.