FDA sends post-market study orders to 33 manufacturers of urogynecologic surgical mesh used for pelvic organ prolapse and to seven makers of single-incision mini-slings used for stress urinary incontinence.
FDA is ordering manufacturers of transvaginal surgical mesh and mini-slings to conduct post-market studies to assess safety complications with the devices used to repair women’s pelvic problems.
On Jan. 3, FDA sent 88 post-market study orders to 33 manufacturers of urogynecologic surgical mesh used for pelvic organ prolapse
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
