by Stephen Levin
Nowhere has the current increased concern of regulators and industry about the long-term safety of medical devices been reflected more...
Novasys: Using Clinical Trials to Drive Adoption for Incontinence
Novasys Medical is using radio frequency (RF) energy to treat stress urinary incontinence in women. The company chose to adopt a much more rigorous and expensive clinical trials strategy than was needed to gain FDA approval of its device. This approach flummoxed the FDA,, slowing approval of the company's IRenessaI system. Novasys is betting that the enhanced data collected from its clinical study will result in the company gaining faster reimbursement that it hopes will drive adoption.
More from Innovation
More from In Vivo
• By
An interactive look at pharma, medtech and diagnostics deals made during May 2025. Data courtesy of Biomedtracker.
• By
Flagship Pioneering senior partner Raj Panjabi discusses shifting health care from reactive treatment to AI-powered prediction and prevention of disease before symptoms emerge.
• By
Namrata Saroj, chief business officer of Ocular Therapeutix, is highly respected in the retina community for her contributions to drug development. She talked to In Vivo about her journey in ophthalmology, leadership philosophy and the importance of authenticity in a close-knit specialty.