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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
Neuralink has succeeded in winning FDA authorization to conduct a first-in-human clinical trial of its implantable brain interface after being denied in 2022 over safety concerns. Read More
The U.S. Patent and Trademark Office (PTO) has found against Longhorn Vaccines & Diagnostics for committing “egregious abuse” of the Patent Trial and Appeal Board (PTAB) process during its review of Longhorn patent claims filed against Spectrum Solutions’ COVID-19 test. Read More