US Food and Drug Administration (FDA)
-
FDA approves MED-EL SYNCHRONY cochlear implant for infants as young as seven months
The FDA’s latest decision also extends the audiologic and speech indications to children aged 12 months and older, broadening the potential patient population who can benefit from this technology.
-
FDA issues draft guidance to reduce primate testing in monoclonal antibody development
Macaque monkeys serve as the most common species for drug testing because they share considerable physiological similarities with humans.
-
Solid Biosciences receives FDA rare pediatric disease designation for Friedreich’s Ataxia Gene Therapy SGT-212
The therapy delivers the full-length human frataxin gene using a dual-administration approach that combines direct intradentate nucleus (IDN) injection with intravenous (IV) infusion.
-
FDA approves GE HealthCare’s AI-powered mammography reconstruction technology
Recon DL is the first mammography technology to combine deep learning with iterative reconstruction methods to enhance digital breast tomosynthesis (DBT) image quality.
-
a2z Radiology AI gains FDA approval for unified abdomen-pelvis CT triage system
Each year in the United States, more than 20 million abdomen-pelvis CT scans are performed, and the volume continues to increase.
-
Novartis gains FDA approval for Itvisma gene therapy to treat spinal muscular atrophy
Itvisma works by delivering a functional copy of the survival motor neuron 1 (SMN1) gene through a single, fixed-dose intrathecal injection.