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The first wireless pulse-oximetry device for infants has received an FDA 510(k) clearance after first receiving a warning letter for selling the device without the agency’s clearance or approval. Read More
New FDA drug approvals in June include new gene therapies for ambulatory Duchenne Muscular Dystrophy and hemophilia A, a treatment for pediatric growth hormone deficiency and the first ever cell therapy for a severe form of type 1 diabetes. Additionally, the FDA approved a new device for skin repigmentation in patients with vitiligo. Read More
Following multiple years of development, the streamlined version of the ClinicalTrials.gov website officially launched Wednesday, providing users with a revised, simplified layout intended to enhance efficiency and usability. Read More
The FDA said this test is an example of the agency’s continued work with test developers that want to market their products beyond emergency use authorities. Read More
Medical devices continue to take advantage of the technological advances we see in every part of our lives, from phones to virtual reality headsets, with several new devices seeing FDA clearances in the past few weeks. Read More
New FDA drug approvals in May include the first vaccine for respiratory syncytial virus, a hot flash treatment for menopausal women, a gene therapy for a rare skin disease and the first and only treatment for a rare hematologic disorder. Additionally, the FDA approved a next-generation sequencing-based companion diagnostic test for solid tumor profiling. Read More
Cue Health’s over-the-counter molecular nucleic acid amplification test (NAAT) for COVID-19 has been granted FDA de novo authorization, making it the first traditionally authorized at-home test for any respiratory illness. Read More
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