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The latest devicemaker to follow an important FDA pathway for technological innovation in devices is French company UroMems, which has snagged a Safer Technologies Program (STeP) designation for its UroActive Smart Continence Therapy device. Read More
The artificial intelligence device can find caries, root canal defects, bone loss, discrepancy at margin, periapical radiolucency and calculus, the company said. Read More
New FDA drug approvals in the past month include treatments for rare diseases and an aggressive form of skin cancer, as well as the first new treatment for invasive fungal infections in over a decade. Additionally, the FDA approved a new device for use in patients with arterial occlusive disease. Read More
Masimo’s Opioid Halo system — the first FDA-authorized monitoring solution for detecting opioid-induced respiratory depression — has been granted a De Novo authorization for sale over the counter and by prescription. Read More