Clinical Trials
57
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
20
35.1%
Not yet recruiting
1
1.8%
Recruiting
6
10.5%
Terminated
6
10.5%
Unknown
11
19.3%
Withdrawn
13
22.8%
No approval data available
- The FDA has granted PreMarket Approval to Womed Leaf®, the first medical device approved in the United States specifically for treating moderate to severe intrauterine adhesions associated with Asherman syndrome. - The device consists of a soft polymer film that prevents uterine wall contact during healing, addressing a condition that affects 20% to 45% of women undergoing procedures like dilation and curettage. - A pivotal clinical study with 160 patients demonstrated that Womed Leaf® significantly reduced adhesion severity compared to no prevention method, offering hope for tens of thousands of women facing infertility. - The device will become available in early 2026, marking a significant advancement for women whose fertility is compromised by recurrent intrauterine scarring.
- The Neuspera percutaneous sacral neuromodulation device demonstrated 84.2% efficacy in reducing urgent urinary leaks by at least 50% in a pivotal Phase 2 trial of 128 patients. - Among responders, 84% achieved greater than 75% reduction in UUI symptoms, while 42% experienced complete symptom elimination, with patients showing 3.5x improvement in quality of life. - The battery-free device, currently under FDA review with a decision expected in 2025, offers comparable effectiveness to traditional SNM devices while eliminating battery-related concerns.
