For Clinicians

Device Overview

The Smart Pessary is an investigational Class II medical device designed to modernize the management of pelvic organ prolapse (POP). For clinicians, it functions much like a traditional pessary for mechanical support, but with the addition of smart technology that provides new insight into patient comfort, adherence, and potential complications.

Made of soft, medical-grade silicone and available in multiple sizes, the Smart Pessary is fitted and managed using familiar clinical techniques. Once in place, its integrated technology can capture data on vaginal health parameters, which—with patient consent—may be shared securely with clinicians. This supports more proactive care between visits.

Clinical Benefits

• Improved Adherence: Designed to address common reasons for pessary discontinuation.

• Early Detection: Potential to alert clinicians to issues between routine appointments.

• Data-Driven Care: Offers objective data on patient use and device performance.

• Ease of Transition: Fitting and follow-up are very similar to existing pessary workflows.

How to Get Involved

• Refer Eligible Patients: We are enrolling in Tucson, AZ (Phase I). Phase II will expand to other sites.

• Participate as a Site: We will invite additional urogynecology centers to join Phase II.

• Request a Demo or Presentation: Available for clinical teams interested in learning more.

• Clinician Resources: A downloadable brief and protocol overview are available on request.

FAQ

• How is it different from a regular pessary?

  It provides standard mechanical support plus integrated monitoring functions.

• Is it FDA-approved?

  Not yet. It is investigational and currently available only through IRB-approved clinical trials.

• How safe is it?

  The device uses biocompatible materials and is undergoing rigorous bench, preclinical, and clinical testing.

• How can my practice participate?

  We welcome interest from clinicians for patient referrals, trial site participation, and future early adoption.

⚠️ Investigational device. Not FDA-cleared. Available only in clinical trials.