FDA Grants De Novo Request for Neuromodulatory System for Urge Incontinence
The FDA has granted a de novo marketing request for the Revi System for tibial neuromodulation to treat urinary incontinence with or without urinary urgency, BlueWind Medical announced on Thursday. The de novo request allows for treatment of men and women with urge urinary incontinence (UUI). Clinicians should follow applicable clinical guidelines and use professional […]
Demand Rising for ‘Bootlegged’ Weight-Loss Drug
Novo Nordisk’s weight management drug semaglutide (Wegovy) has been in prolonged short supply due to “unprecedented demand,” prompting increased — and questionable — interest in compounded formulations of the drug, physicians said. Endocrinologists and obesity medicine specialists have been sounding the alarm about what they say amounts to bootleg semaglutide, concerned about safety and quality […]