The FDA has granted the authorization of 510 (K) to the Glean Urodynamics system for adult patients with lower urinary tract dysfunction (LUTD), Bright Uro announced in a press release.1
The device allows monitoring of ambulatory urodynamics without catheters and without catheter.
According to the company, the system is a “urodynamic analyzer system that is intended to quantify the pressure and flow characteristics of the lower urinary tract.” The device allows monitoring of wireless outpatient urodynamics and without catheter that can help decision making.
“I think that Glean is the type of diagnostic technology progress that the Urology community has waited for decades,” said Alan J. Wein, MD, of the University of Miami, Florida, in the press release.1 “The system produces information that is closer to a real life situation that is generated in a Urodia laboratory. Symptomatology and, therefore, improving the patient’s care.”
Bright Uro shared that it was found that the Glean system was easier to use for doctors, delivered more precise data and was more comfortable for patients.
In a previous press release, 2 the company explained: “The Glean system consists of an insertion tool, a pressure sensor enabled with Bluetooth in a flexible silicone tube, a software application to use by doctors and patients, and a Uroflowo meter to detect volume and flow.”
Bright Uro also explained that the system without catheter of the system can allow doctors to collect more outpatient data with greater physiological precision compared to current care options.
“Most urologists, including myself, believe that current urodynamic tests are missing,” said Bilal I. Choughtai, MD, of Northwell Health in New York.1 “With the artificial filling and cancellation of catheters in their place, patients often cannot replicate the symptoms during the test.
The Glean Urodynamics system was developed by researchers at the Cleveland Clinic, in collaboration with teams from the Department of Veterans Affairs, Case Western Reserve and Parker Hannifin Corporation. Bright Uro now has an exclusive license agreement for technology.
“Today, some suppliers renounce urodynamics due to a shortage of teams and nurses trained to administer the test,” said Melissa R. Kaufman, MD, PHD, FACS, from the University of Vanderbilt in Nashville, Tennessee.1 “Give Diagnostic diagnosis information “.
References
1. Bright Uro receives authorization from the FDA for the Glean Urodynamics system. Press release. Bright uro. Published online and accessed on April 2, 2025. https://www.businesswire.com/news/home/20250402777960/en/bright-uro-receives-fda-clarance-for-glean-urodynamics-system
2. Bright Uro is launched with $ 6 million in seed financing and subsidy of the National Health Institutes. Press release. June 9, 2022. Accessed April 2, 2025. https://www.businesswire.com/news/home/20220609005264/en/bright-uro-launches-with-%246-million-in-nancing-y-grant-nation
