FDA Clears Zenflow’s Single-Use Cystoscope

Zenflow has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Zenflow Spring scope and camera control unit (CCU).

The Spring scope, according to the company, is the first single-use cystoscope of its kind. It touts a 12 French working channel, which is over 80% larger than current single-use models. This lets urologists perform procedures with better visualization while maintaining comfort for the patient.

Flexible cystoscopy, the most common in-office procedure done by urologists, is crucial to diagnose and treat lower urinary tract conditions. In the U.S., about 1.2 million are performed annually.

“This new cystoscope technology delivers clear imaging while also allowing us to provide advanced diagnostics and therapeutics in the comfort of our office,” said Bilal Chughtai, M.D., Chief of Urology at Plainview Hospital and investigator of the Zenflow Spring system. “It’s an exciting and much-anticipated innovation in the field.”

The system was designed to optimize the experience for men living with benign prostatic hyperplasia (BPH) symptoms.

“We’re thrilled to receive FDA clearance for Zenflow’s first product,” added Shreya Mehta, CEO of Zenflow. “With advanced imaging, catheter flexibility, and a large working channel, the Spring Scope is a meaningful innovation in its own right, and a key enabler and differentiator for our forthcoming BPH therapy, the Zenflow Spring Implant and Delivery System. This progress reflects our commitment to bringing patient-focused innovation to urologists and their patients.”

In January of this year, the company closed a $24 million Series C financing round that supported the submission of the Spring system.