The PDUFA target action date is in the fourth quarter of 2026.
|Articles|May 13, 2004
Vaginal vault repair system receives FDA clearance
American Medical Systems announced Monday that its Apogee System forvaginal vault prolapse repair received FDA clearance. The company said itwill begin physician training in preparation for commercial release laterthis year.
Advertisement
Advertisement
Related to this article
The approval is supported by data from the phase 3 LITESPARK-011 trial.
Pearls & Perspectives: Expanding Sexual Health Conversations Through Digital Media, With Wendy Brant
Amy Pearlman, MD, and Wendy Brant discuss building a digital audience, navigating sexual health content online, and the role of communication in relationships.
Positive safety and efficacy data from 4 clinical studies supported the CE marking.
Sandip Prasad, MD, discusses patient selection for chemoablation in recurrent LG-IR-NMIBC and considerations when counseling patients about a nonsurgical approach.
In a head-to-head RCT, Rezūm produced a 4.6-point greater IPSS improvement than combination pharmacotherapy at 1 year, according to Jean-Nicolas Cornu, MD, PhD, FEBU.
The AACU and the WOCN Society urge CMS to protect access to individualized catheter and ostomy supplies as competitive bidding begins in 2028.
Better detection has changed prostate cancer care. Patients choosing radical treatment still need better protection from the disease returning.
Advertisement
Advertisement
Trending on Urology Times
1
FDA approves belzutifan plus lenvatinib for advanced clear cell renal cell carcinoma
2
After curative-intent treatment, prostate cancer recurrence is still an unmet need
3
Sandip Prasad, MD, on patient selection for chemoablation in LG-IR-NMIBC
4
FemPulse Ring receives EU approval for overactive bladder
5